NameOverall Response RateDuration of ResponseProgression-Free SurvivalOverall SurvivalComplete ResponsePartial ResponseEfficacy evaluation trial detailsCommon adverse reactionsOther important risksRecommended dosageApproval dateArticle URL
"Epcoritamab-bysp (Epkinly)""82%""NR""NA""NA""60%""NA"{"Study":"EPCORE NHL-1 (Study GCT3013-01; NCT03625037)","Population":"127 patients with relapsed or refractory FL after at least 2 lines of systemic therapy","Primary Efficacy Measures":{"ORR":"82% (95% CI: 74.1, 88.2)","DOR":"NR (95% CI: 13.7, NR)"}}["Injection site reactions","Cytokine release syndrome","COVID-19 infection","Fatigue","Upper respiratory tract infection","Musculoskeletal pain","Rash","Diarrhea","Pyrexia","Cough","Headache"]{"Boxed Warning":"Serious or fatal cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity (ICANS)","Warnings and Precautions":{"Serious infections":"40%","Cytopenias":"NA","ICANS occurrence":"6.0%","Serious infections occurrence":"40%"}}{"Regimen":"Administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity","Recommended dose schedule":[{"Cycle 1":"0.16 mg on Day 1, 0.8 mg on Day 8, 3 mg on Day 15, and 48 mg on Day 22","Cycle 2 and 3":"48 mg on Days 1, 8, 15, and 22","Cycles 4 to 9":"48 mg on Days 1 and 15","Cycle 10 and beyond":"48 mg on Day 1"}]}2024-06-26https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma
"adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab""34%""5.8 months""NA""NA""NA""All responses were partial responses""Efficacy was evaluated in KRYSTAL-1, a multicenter, single-arm expansion cohort trial. In the 94 enrolled patients, ORR was 34% (95% CI: 25%, 45%), all responses were partial responses, and median DOR was 5.8 months (95% CI: 4.2, 7.6). Thirty-one percent of responding patients had a DOR of at least 6 months."["rash","nausea","diarrhea","vomiting","fatigue","musculoskeletal pain","hepatotoxicity","headache","dry skin","abdominal pain","decreased appetite","edema","anemia","cough","dizziness","constipation","peripheral neuropathy"]"NA""The recommended adagrasib dose is 600 mg orally twice daily until disease progression or unacceptable toxicity. Refer to the cetuximab prescribing information for cetuximab dosage information."2024-06-21https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
"pembrolizumab (Keytruda, Merck)""NA""NA"{"dMMR cohort":{"pembrolizumab and chemotherapy arm":"NR","placebo and chemotherapy arm":"6.5 months","Hazard ratio":0.3,"p-value":"<0.0001"},"pMMR cohort":{"pembrolizumab and chemotherapy arm":"11.1 months","placebo and chemotherapy arm":"8.5 months","Hazard ratio":0.6,"p-value":"<0.0001"}}"NA""NA""NA""KEYNOTE-868\/NRG-GY018 (NCT03914612) trial for primary advanced or recurrent endometrial carcinoma"[{"pembrolizumab and chemotherapy":"similar to those previously reported with a higher incidence of rash"}]"NA""200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months"2024-06-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-primary-advanced-or-recurrent-endometrial-carcinoma
"blinatumomab (Blincyto, Amgen Inc.)""NA""NA""NA"{"3-year":{"blinatumomab arm":"84.8%","chemotherapy arm":"69%"},"5-year":{"blinatumomab arm":"82.4%","chemotherapy arm":"62.5%"}}"NA""NA"{"Study E1910 (NCT02003222)":{"Population":"Adult patients with newly diagnosed Ph-negative BCP ALL","Randomization":"1:1 blinatumomab arm vs. chemotherapy arm","Number of patients":"112 in each arm","Major outcome measure":"Overall Survival (OS)"},"Study 20120215 (NCT02393859)":{"Population":"Pediatric and young adult patients with Ph-negative BCP ALL","Randomization":"1:1 blinatumomab arm vs. chemotherapy arm","Number of patients":"54 in blinatumomab arm, 57 in chemotherapy arm","Major outcome measures":{"OS":{"5-year":{"blinatumomab arm":"78.4%","chemotherapy arm":"41.4%"}},"RFS":{"5-year":{"blinatumomab arm":"61.1%","chemotherapy arm":"27.6%"}}}}}["neutropenia","thrombocytopenia","anemia","leukopenia","headache","infection","nausea","lymphopenia","diarrhea","musculoskeletal pain","tremor","pyrexia","rash","hypogammaglobulinemia"]"NA""See full prescribing information for recommended dose by patient weight and schedule"2024-06-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell
"durvalumab (Imfinzi, AstraZeneca UK Limited)""NA""NA""Improvement observed in the overall population primarily attributed to patients with dMMR tumors""Immature at the PFS analysis""NA""NA""DUO-E (NCT04269200), a randomized, multicenter, double-blind, placebo-controlled trial in patients with primary advanced or recurrent endometrial cancer"["peripheral neuropathy","musculoskeletal pain","nausea","alopecia","fatigue","abdominal pain","constipation","rash","diarrhea","vomiting","cough"]"NA""For patients with a body weight \u2265 30 kg: 1,120 mg with carboplatin plus paclitaxel every 3 weeks for 6 cycles, followed by single-agent durvalumab 1,500 mg every 4 weeks. For patients with a body weight of < 30 kg: 15 mg\/kg with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by durvalumab 20 mg\/kg every 4 weeks."2024-06-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent
"repotrectinib (AUGTYRO, Bristol-Myers Squibb Company)""58% in TKI-na\u00efve group, 50% in TKI-pretreated group""NE in TKI-na\u00efve group, 9.9 months in TKI-pretreated group""NA""NA""NA""NA""TRIDENT-1 (NCT03093116), multicenter, single-arm, open-label, multi-cohort trial in 88 adult patients with locally advanced or metastatic NTRK gene fusion-positive solid tumors"["dizziness","dysgeusia","peripheral neuropathy","constipation","dyspnea","fatigue","ataxia","cognitive impairment","muscular weakness","nausea"]"NA""160 mg orally once daily for 14 days, then increased to 160 mg twice daily with or without food, until disease progression or unacceptable toxicity"2024-06-13https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-repotrectinib-adult-and-pediatric-patients-ntrk-gene-fusion-positive
"selpercatinib (Retevmo, Eli Lilly and Company)"{"previously treated patients":"85%","systemic therapy naive patients":"96%"}{"previously treated patients":"26.7 months","systemic therapy naive patients":"Not Evaluable"}"NA""NA""NA""NA"{"trials":["LIBRETTO-001 (NCT03157128)","LIBRETTO-121 (J2G-OX-JZJJ; NCT03899792)"],"Supportive evidence":"ORR 60% in pediatric and young adult patients with RET fusion-positive thyroid cancer"}["edema","diarrhea","fatigue","dry mouth","hypertension","abdominal pain","constipation","rash","nausea","headache"]{"Grade 3 or 4 laboratory abnormalities":["decreased lymphocytes","increased alanine aminotransferase (ALT)","increased aspartate aminotransferase (AST)","decreased sodium","decreased calcium"]}{"Pediatric patients 2 to less than 12 years of age":"Based on body surface area","Patients 12 years of age and older":"Based on weight"}2024-06-12https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-ret-fusion-positive-thyroid-cancer
"imetelstat (Rytelo)""NA""NA""NA""NA""NA""NA"{"Trial Name":"IMerge (NCT02598661)","Trial Type":"Randomized (2:1), double-blind, placebo-controlled multicenter trial","Patient Count":178,"Imetelstat Dosage":"7.1 mg\/kg","Treatment Regimen":"Intravenous infusion in 28-day cycles","Follow-up Time":{"Imetelstat Group":"19.5 months (range: 1.4 to 36.2)","Placebo Group":"17.5 months (range: 0.7 to 34.3)"},"RBC-TI Rates":{"\u2265 8-week RBC-TI":{"Imetelstat Group":"39.8% (95% CI: 30.9, 49.3)","Placebo Group":"15% (95% CI: 7.1, 26.6)","p-value":"< 0.001"},"\u2265 24-week RBC-TI":{"Imetelstat Group":"28% (95% CI: 20.1, 37)","Placebo Group":"3.3% (95% CI: 0.4, 11.5)","p-value":"< 0.001"}}}["decreased platelets","decreased white blood cells","decreased neutrophils","increased aspartate aminotransferase","increased alkaline phosphatase","increased alanine aminotransferase","fatigue","prolonged partial thromboplastin time","arthralgia\/myalgia","COVID-19 infections","headache"]"NA""7.1 mg\/kg administered as an intravenous infusion over 2 hours every 4 weeks"2024-06-06https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-imetelstat-low-intermediate-1-risk-myelodysplastic-syndromes-transfusion-dependent
"lisocabtagene maraleucel (Breyanzi)""85.3%""13.3 months""NA""NA""67.6%""NA""TRANSCEND-MCL (NCT02631044), open-label, multicenter, single-arm trial in adult patients with relapsed or refractory MCL"["Cytokine release syndrome (CRS)","Fatigue","Musculoskeletal pain","Encephalopathy","Edema","Headache","Decreased appetite"]"Risk of fatal or life-threatening CRS and neurologic toxicities""90 to 110 \u00d7 10^6 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components"2024-05-30https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma
"selpercatinib (Retevmo, Eli Lilly and Company)""48%""Not reached""NA""NA""NA""NA""LIBRETTO-121 (NCT03899792), an international, single-arm, multi-cohort trial"["musculoskeletal pain","diarrhea","headache","nausea","vomiting","coronavirus infection","abdominal pain","fatigue","pyrexia","hemorrhage"]"NA""The recommended selpercatinib dose for pediatric patients 2 to less than 12 years of age is based on body surface area. It is based on weight for patients 12 years of age and older. See the prescribing information for specific dosing information."2024-05-29https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selpercatinib-pediatric-patients-two-years-and-older-ret-altered
"tarlatamab-dlle (Imdelltra, Amgen, Inc.)""40%""9.7 months""NA""NA""NA""NA""Efficacy was evaluated in 99 patients with relapsed\/refractory ES-SCLC with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study."["cytokine release syndrome (CRS)","fatigue","pyrexia","dysgeusia","decreased appetite","musculoskeletal pain","constipation","anemia","nausea"]"Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).""Initial dose of 1 mg administered as an intravenous infusion over 1 hour on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15 then every 2 weeks thereafter until disease progression or unacceptable toxicity."2024-05-16https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
"lisocabtagene maraleucel (Breyanzi)""95.7%""Not reached""NA""NA""NA""NA""Phase 2, open-label, multicenter, single-arm trial (TRANSCEND-FL)"["Cytokine release syndrome (CRS)","Headache","Musculoskeletal pain","Fatigue","Constipation","Fever"]"FDA approved with a Risk Evaluation and Mitigation Strategy due to the risk of fatal or life-threatening CRS and neurologic toxicities""90 to 110 \u00d7 10^6 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components"2024-05-15https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma
"Tivdak""17.8%""NA""4.2 months""11.5 months""NA""NA""innovaTV 301 (NCT04697628), an open-label, active-controlled, multicenter, randomized trial with 502 patients"["decreased hemoglobin","peripheral neuropathy","conjunctival adverse reactions","increased aspartate aminotransferase","nausea","increased alanine aminotransferase","fatigue","decreased sodium","epistaxis","constipation"]"NA""2 mg\/kg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity"2024-04-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
"Ojemda (tovorafenib)""51%""13.8 months""NA""NA""NA""NA""FIREFLY-1 (NCT04775485), a multicenter, open-label, single-arm trial in patients with relapsed or refractory pediatric LGG harboring an activating BRAF alteration detected by a local laboratory who had received at least one line of prior systemic therapy."["rash","fatigue","vomiting","headache","pyrexia","constipation","nausea","dry skin","dermatitis acneiform","upper respiratory tract infection"]"NA""380 mg\/m2 orally once weekly (up to a maximum dose of 600 mg) with or without food until disease progression or intolerable toxicity"2024-04-23https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-relapsed-or-refractory-braf-altered-pediatric
"lutetium Lu 177 dotatate (Lutathera)""NA""NA""NA""NA""NA""NA"{"Study":"NETTER-P (NCT04711135)","Design":"Ongoing, international, multi-center, open-label, single-arm study","Patient population":"Adolescent patients with locally advanced\/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma\/paraganglioma (PPGL)"}["Absorbed radiation doses in target organs","Incidence of adverse reactions after the first treatment cycle"]"NA""7.4 GBq (200 mCi) every 8 weeks (\u00b1 1 week) for a total of 4 doses"2024-04-23https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets
"nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Gu\u00e9rin (BCG)""NA""NA""NA""NA""62% (95% CI: 51, 73)""NA"{"Trial Name":"QUILT-3.032 (NCT0302285)","Number of Patients":77,"Disease Type":"BCG-unresponsive, high-risk NMIBC with CIS with or without Ta\/T1 papillary disease","Treatment":"nogapendekin alfa inbakicept-pmln induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months"}["increased creatinine","dysuria","hematuria","urinary frequency","micturition urgency","urinary tract infection","increased potassium","musculoskeletal pain","chills","pyrexia"]"NA"{"Induction Therapy":"400 mcg administered intravesically with BCG once a week for 6 weeks","Second Induction Course":"400 mcg administered intravesically with BCG if CR is not achieved at month 3","Maintenance Therapy":"400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19"}2024-04-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer
"Alectinib (Alecensa)""NA""NA""NA""NA""NA""NA""Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients were required to have resectable Stage IB (tumors \u2265 4 cm) to IIIA NSCLC (by AJCC 7th edition) with ALK rearrangements identified by a locally performed FDA-approved ALK test or by a centrally performed VENTANA ALK (D5F3) CDx assay. A total of 257 patients were randomized (1:1) to receive alectinib 600 mg orally twice daily or platinum-based chemotherapy following tumor resection."["Hepatotoxicity","Constipation","Myalgia","COVID-19","Fatigue","Rash","Cough"]"NA""The recommended alectinib dose is 600 mg orally twice daily with food for 2 years or until disease recurrence or unacceptable toxicity."2024-04-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer
"null""null""null""null""null""null""null""null""null""null""null"2024-04-05https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2
"mirvetuximab soravtansine-gynx (Elahere)""42%""NA""5.6 months""16.5 months""NA""NA""Study 0416 (MIRASOL, NCT04209855), a multicenter, open-label, active-controlled, randomized, two-arm trial in 453 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer."["increased aspartate aminotransferase","fatigue","increased alanine aminotransferase","blurred vision","nausea","increased alkaline phosphatase","diarrhea","abdominal pain","keratopathy","peripheral neuropathy","musculoskeletal pain","decreased lymphocytes","decreased platelets","decreased magnesium","decreased hemoglobin","dry eye","constipation","decreased leukocytes","vomiting","decreased albumin","decreased appetite","decreased neutrophils"]"Ocular toxicity, pneumonitis, peripheral neuropathy, embryo-fetal toxicity""6 mg\/kg adjusted ideal body weight administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity"2024-03-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian
"Fluorouracil injection""NA""NA""NA""NA""NA""NA""NA"["risk of serious adverse reactions in patients with DPD deficiency"]"NA""NA"2024-03-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-safety-labeling-changes-regarding-dpd-deficiency-fluorouracil-injection-products
"Iclusig (ponatinib)""NA""NA""NA""NA""30%""NA""PhALLCON (NCT03589326), randomized trial of 245 adult patients with newly diagnosed Ph+ ALL comparing ponatinib with imatinib plus chemotherapy"["Hepatic dysfunction","Arthralgia","Rash and related conditions","Headache","Pyrexia","Abdominal pain","Constipation","Fatigue","Nausea","Oral mucositis","Hypertension","Pancreatitis\/elevated lipase","Peripheral neuropathy","Hemorrhage","Febrile neutropenia","Fluid retention and edema","Vomiting","Paresthesia","Cardiac arrhythmias"]"NA""30 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of MRD-negative CR at the end of induction. Continue with chemotherapy for up to 20 cycles until loss of response or unacceptable toxicity."2024-03-19https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome
"zanubrutinib (Brukinsa)""69% (ZO arm) and 46% (obinutuzumab arm)""Not reached in ZO arm and 14.0 months in obinutuzumab arm""NA""NA""NA""NA""Study BGB-3111-212 (ROSEWOOD; NCT03332017) evaluated zanubrutinib with obinutuzumab in 217 adult patients with relapsed or refractory FL after at least 2 prior systemic treatments"["Decreased neutrophil counts - 51%","Platelet counts - 41%","Upper respiratory tract infection - 38%","Hemorrhage - 32%","Musculoskeletal pain - 31%"]"Serious adverse reactions occurred in 35% of patients with FL who received ZO""160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity"2024-03-07https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
"nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine""NA""NA""7.9 months""21.7 months""NA""NA""CHECKMATE-901 (NCT03036098), randomized, open-label trial enrolling 608 patients with previously untreated unresectable or metastatic UC"["nausea","fatigue","musculoskeletal pain","constipation","decreased appetite","rash","vomiting","peripheral neuropathy","urinary tract infection","diarrhea","edema","hypothyroidism","pruritis"]"NA"{"Combination therapy":"360 mg nivolumab every 3 weeks with cisplatin and gemcitabine every 3 weeks for up to 6 cycles","Single agent therapy":"240 mg nivolumab every 2 weeks or 480 mg every 4 weeks until disease progression, unacceptable toxicity, or a maximum treatment of 2 years from first dose"}2024-03-07https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-combination-cisplatin-and-gemcitabine-unresectable-or-metastatic-urothelial
"null""null""null""null""null""null""null""null""null""null""null"2024-03-06https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-pediatric-patients-acute-lymphoblastic-leukemia
"amivantamab-vmjw (Rybrevant)""NA""NA""11.4 months""Not available""NA""NA""PAPILLON (NCT04538664), a randomized, open-label multicenter trial of 308 patients with EGFR exon 20 insertion mutations, comparing amivantamab-vmjw with carboplatin and pemetrexed versus carboplatin and pemetrexed"["Rash","Nail toxicity","Stomatitis","Infusion-related reaction","Fatigue","Edema","Constipation","Decreased appetite","Nausea","COVID-19","Diarrhea","Vomiting"]"NA""Based on body weight. See prescribing information for specific dosage information."2024-03-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications
"null""null""null""null""null""null""null""null""null""null""null"2024-02-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer
"lifileucel""31.5%""Not reached""NA""NA""NA""NA""Global, multicenter, multicohort, open-label, single-arm trial in patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor."["chills","pyrexia"]"Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment""7.5 x 10^9 to 72 x 10^9 viable cells"2024-02-16https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma
"null""null""null""null""null""null""null""null""null""null""null"2024-02-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer
["Onivyde"]["41.8% in the NALIRIFOX arm","36.2% in the Gem+NabP arm"]"NA"["7.4 months in the NALIRIFOX arm","5.6 months in the Gem+NabP arm"]["11.1 months in the NALIRIFOX arm","9.2 months in the Gem+NabP arm"]"NA""NA""NAPOLI 3 (NCT04083235), a randomized, multicenter, open-label, active-controlled trial in 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy in the metastatic setting."["diarrhea","fatigue","nausea","vomiting","decreased appetite","abdominal pain","mucosal inflammation","constipation","decreased weight"]{"Laboratory abnormalities":["decreased neutrophils","decreased potassium","decreased lymphocyte","decreased hemoglobin"]}"The recommended irinotecan liposome dose is 50 mg\/m2 administered by intravenous infusion over 90 minutes every 2 weeks."2024-02-13https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma
"erdafitinib (Balversa, Janssen Biotech)""35.3%""NA""5.6 months""12.1 months""NA""NA""The efficacy of erdafitinib was evaluated in Study BLC3001 Cohort 1, where statistically significant improvements in OS, PFS, and ORR were demonstrated compared with chemotherapy."["increased phosphate","nail disorders","diarrhea","stomatitis","increased alkaline phosphatase","decreased hemoglobin","increased alanine aminotransferase","increased aspartate aminotransferase","decreased sodium","increased creatinine","dry mouth","decreased phosphate","palmar-plantar erythrodysesthesia syndrome","dysgeusia","fatigue","dry skin","constipation","decreased appetite","increased calcium","alopecia","dry eye","increased potassium","decreased weight"]"NA""8 mg orally once daily, with a dose increase to 9 mg once daily based on tolerability, including hyperphosphatemia, at 14 to 21 days. Treatment should continue until disease progression or unacceptable toxicity."2024-01-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-erdafitinib-locally-advanced-or-metastatic-urothelial-carcinoma
"pembrolizumab (Keytruda, Merck)""NA""NA""significant improvement in PFS in the overall population, with a PFS HR estimate of 0.59 (95% CI: 0.43, 0.82) in patients with FIGO 2014 Stage III-IVA disease""OS data not mature at the time of PFS analysis""NA""NA""KEYNOTE-A18 (NCT04221945), multicenter, randomized, double-blind, placebo-controlled trial enrolling 1060 patients with cervical cancer"["nausea","diarrhea","vomiting","urinary tract infection","fatigue","hypothyroidism","constipation","decreased appetite","weight loss","abdominal pain","pyrexia","hyperthyroidism","dysuria","rash","pelvic pain"]"NA""200 mg IV every 3 weeks or 400 mg IV every 6 weeks until disease progression or unacceptable toxicity, administered before chemoradiotherapy when given on the same day"2024-01-12https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemoradiotherapy-figo-2014-stage-iii-iva-cervical-cancer
"null""null""null""null""null""null""null""null""null""null""null"2023-12-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic-urothelial-cancer
["belzutifan (Welireg, Merck & Co., Inc.)"]"NA""NA"{"Value":"5.6 months","Confidence Interval":"95% CI: 3.9, 7.0"}"NA""NA""NA""LITESPARK-005 (NCT04195750)"["decreased hemoglobin","fatigue","musculoskeletal pain","increased creatinine","decreased lymphocytes","increased alanine aminotransferase","decreased sodium","increased potassium","increased aspartate aminotransferase"]"NA""120 mg administered orally once daily until disease progression or unacceptable toxicity"2023-12-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma
"null""null""null""null""null""null""null""null""null""null""null"2023-12-13https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-eflornithine-adult-and-pediatric-patients-high-risk-neuroblastoma
"Jaypirca""72%""12.2 months""NA""NA""NA""All responses were partial responses""BRUIN (NCT03740529), 108 patients with CLL or SLL previously treated with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor"["fatigue","bruising","cough","musculoskeletal pain","COVID-19","diarrhea","pneumonia","abdominal pain","dyspnea","hemorrhage","edema","nausea","pyrexia","headache"]"Serious infections occurred in 32% of patients including fatal infections in 10% of patients. Warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, and secondary primary malignancies""200 mg orally once daily until disease progression or unacceptable toxicity"2023-12-01https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic
"nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.)""41%""NA""Median PFS was not reached in the nirogacestat arm""NA""NA""NA""DeFi (NCT03785964), an international, multicenter, randomized (1:1), double-blind, placebo-controlled trial in 142 patients with progressing desmoid tumors not amenable to surgery"["diarrhea","ovarian toxicity","rash","nausea","fatigue","stomatitis","headache","abdominal pain","cough","alopecia","upper respiratory tract infection","dyspnea"]"NA""150 mg administered orally twice daily with or without food until disease progression or unacceptable toxicity. Each 150 mg dose consists of three 50 mg tablets."2023-11-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-desmoid-tumors
"Enzalutamide (Xtandi)""NA""NA""NA""NA""NA""NA"{"Trial Name":"EMBARK (NCT02319837)","Patient Population":"1068 patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence","Treatment Groups":[{"Enzalutamide + Leuprolide":"Blinded enzalutamide 160 mg once daily plus leuprolide"},{"Enzalutamide Monotherapy":"Open-label single-agent enzalutamide 160 mg once daily"},{"Placebo + Leuprolide":"Blinded placebo once daily plus leuprolide"}],"Major Efficacy Measure":{"Metastasis-Free Survival (MFS)":{"Comparison 1":"Enzalutamide + Leuprolide vs. Placebo + Leuprolide","Comparison 2":"Enzalutamide Monotherapy vs. Placebo + Leuprolide","Results":{"Comparison 1 HR":0.42,"Comparison 1 CI":"0.30, 0.61","Comparison 1 p-value":"<0.0001","Comparison 2 HR":0.63,"Comparison 2 CI":"0.46, 0.87","Comparison 2 p-value":"0.0049"}},"Other Efficacy Measures":["Overall Survival (OS) - Data immature at the time of MFS analysis"]}}["Enzalutamide + Leuprolide: Hot flush, Musculoskeletal pain, Fatigue, Fall, Hemorrhage","Enzalutamide Monotherapy: Fatigue, Gynecomastia, Musculoskeletal pain, Breast tenderness, Hot flush, Hemorrhage"]"NA""160 mg orally once daily with or without food until disease progression or unacceptable toxicity"2023-11-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-non-metastatic-castration-sensitive-prostate-cancer-biochemical-recurrence
"capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant""NA""NA"{"Overall Population":"NA","PIK3CA\/AKT1\/PTEN-alteration population":"7.3 months"}"NA""NA""NA"{"Trial Name":"CAPItello-291 (NCT04305496)","Trial Type":"Randomized, double-blind, placebo-controlled, multicenter trial","Number of Patients":"708","Inclusion Criteria":"Locally advanced or metastatic HR-positive, HER2-negative breast cancer with PIK3CA\/AKT1\/PTEN-alterations","Treatment Regimen":"Capivasertib 400 mg or placebo + Fulvestrant 500 mg","Outcome Measure":"Investigator-assessed progression-free survival (PFS)"}["Diarrhea","Cutaneous adverse reactions","Increased random glucose","Decreased lymphocytes","Decreased hemoglobin","Increased fasting glucose","Nausea","Fatigue","Decreased leukocytes","Increased triglycerides","Decreased neutrophils","Increased creatinine","Vomiting","Stomatitis"]"NA""400 mg orally twice daily (with or without food), 4 days on followed by 3 off days"2023-11-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer
"pembrolizumab (Keytruda, Merck)""51%""8 months""6.9 months""12.9 months""NA""NA""KEYNOTE-859 (NCT03675737), multicenter, randomized, double-blind, placebo-controlled trial in 1579 patients with HER2-negative advanced gastric or GEJ adenocarcinoma"["infections","diarrhea"]"NA""200 mg every 3 weeks or 400 mg every 6 weeks until disease progression or unacceptable toxicity"2023-11-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-her2-negative-gastric-or-gastroesophageal-junction
"null""null""null""null""null""null""null""null""null""null""null"2023-11-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-ros1-positive-non-small-cell-lung-cancer
"fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.)""NA""NA""NA"{"FRESCO-2":{"Treatment Arm":"Fruquintinib","Median OS":"7.4 months","95% CI":"[4.0, 5.8]","Placebo Group Median OS":"4.8 months","Hazard Ratio":"0.66","P-value":"< 0.001"},"FRESCO":{"Treatment Arm":"Fruquintinib","Median OS":"9.3 months","95% CI":"[5.9, 8.1]","Placebo Group Median OS":"6.6 months","Hazard Ratio":"0.65","P-value":"< 0.001"}}"NA""NA"{"FRESCO-2":{"Trial ID":"NCT04322539","Type":"Randomized, double-blind, placebo-controlled trial","Number of Patients":"691","Inclusion Criteria":"mCRC patients with disease progression post-prior chemotherapy and biological therapy"},"FRESCO":{"Trial ID":"NCT02314819","Type":"Multicenter placebo-controlled trial","Number of Patients":"416","Inclusion Criteria":"mCRC patients with disease progression post-prior chemotherapy"}}["Hypertension","Palmar-plantar erythrodysesthesia","Proteinuria","Dysphonia","Abdominal pain","Diarrhea","Asthenia"]"NA"{"Dosage":"5 mg orally once daily","Administration":"With or without food","Treatment Cycle":"First 21 days of each 28-day cycle","Duration":"Until disease progression or unacceptable toxicity"}2023-11-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancer
"null""null""null""null""null""null""null""null""null""null""null"2023-11-07https://fda.gov/drugs/resources-information-approved-drugs/fda-amends-pembrolizumabs-gastric-cancer-indication
"pembrolizumab (Keytruda, Merck)""NA""NA""NA"{"value":"12.7 months","confidence_interval":"11.5, 13.6"}"NA""NA"{"trial_name":"KEYNOTE-966 (NCT04003636)","trial_type":"multicenter, randomized, double-blind, placebo-controlled","patient_enrollment":"1069 patients","treatment_arms":[{"arm_name":"pembrolizumab plus gemcitabine and cisplatin","arm_ratio":"1:1"},{"arm_name":"placebo plus gemcitabine and cisplatin","arm_ratio":"1:1"}],"treatment_schedule":"pembrolizumab on Day 1 plus gemcitabine and cisplatin on Day 1 and Day 8 every 3 weeks, or placebo on Day 1 plus gemcitabine and cisplatin on the above schedule","treatment_duration":"until unacceptable toxicity or disease progression"}[{"reaction":"decreased neutrophil count"},{"reaction":"decreased platelet count"},{"reaction":"anemia"},{"reaction":"decreased white blood cell count"},{"reaction":"pyrexia"},{"reaction":"fatigue"},{"reaction":"cholangitis"},{"reaction":"increased ALT"},{"reaction":"increased AST"},{"reaction":"biliary obstruction"}]"NA"{"dosage":"200 mg every 3 weeks or 400 mg every 6 weeks","administration_timing":"prior to chemotherapy when given on the same day"}2023-10-31https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-biliary-tract-cancer
"null""null""null""null""null""null""null""null""null""null""null"2023-10-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma
"Tibsovo""38.9%""Not estimable (range 1.9, 80.8+ months)""NA""NA""38.9% (95% CI: 17.3, 64.3)""NA""Trial AG120-C-001 (NCT02074839), an open-label, single-arm, multicenter trial of 18 adult patients"["GI toxicities (diarrhea, constipation, mucositis, and nausea)","arthralgia, fatigue, cough, myalgia, and rash"]"QTc prolongation, differentiation syndrome""Ivosidenib was administered orally at a starting dose of 500 mg daily continuous for 28-day cycles"2023-10-24https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-myelodysplastic-syndromes
"entrectinib (Rozlytrek)""70%""25.4 months""NA""NA""NA""NA""Efficacy in NTRK-positive tumors was investigated in 33 pediatric patients who received entrectinib..."["pyrexia","constipation","increased weight","vomiting","diarrhea","nausea"]"NA""The recommended dose for pediatric patients > 1 month to \u2264 6 months of age is 250 mg\/m2 orally once daily. The recommended dose for pediatric patients > 6 months is based on body surface area (up to a maximum of 600 mg once daily)."2023-10-20https://fda.gov/drugs/resources-information-approved-drugs/fda-expands-pediatric-indication-entrectinib-and-approves-new-pellet-formulation
"null""null""null""null""null""null""null""null""null""null""null"2023-10-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-adjuvant-pembrolizumab-resectable-non-small-cell-lung-cancer
"nivolumab (Opdivo, Bristol-Myers Squibb Company)""NA""NA""Median RFS was not reached in either the nivolumab arm (95% CI: 28.5, not reached) or in the placebo arm (95% CI: 21.6, not reached) (hazard ratio=0.42 [95% CI: 0.30, 0.59]; p-value=<0.0001)""NA""NA""NA""Enrollment required complete resection of the primary melanoma with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization, and ECOG performance status of 0 or 1. The trial excluded patients with ocular\/uveal or mucosal melanoma, autoimmune disease, any condition requiring systemic treatment with either corticosteroids (\u226510 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as those with prior melanoma therapy except surgery. Randomization was stratified by AJCC 8th staging system edition (T3b vs. T4a vs. T4b)"["fatigue","musculoskeletal pain","rash","diarrhea","pruritis"]"NA""The recommended nivolumab dose for patients weighing 40 kg or greater is 240 mg every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity for up to 1 year. The recommended dose for pediatric patients weighing less than 40 kg is 3 mg\/kg every 2 weeks or 6 mg\/kg every 4 weeks until disease progression or unacceptable toxicity for up to 1 year"2023-10-13https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-stage-iibc-melanoma
["encorafenib (Braftovi)","binimetinib (Mektovi)"]{"Treatment-na\u00efve patients":"75%","Previously treated patients":"46%"}{"Treatment-na\u00efve patients":"Not estimable (NE)","Previously treated patients":"16.7 months"}"NA""NA""NA""NA""PHAROS (NCT03915951), open-label, multicenter, single-arm study"["fatigue","nausea","diarrhea","musculoskeletal pain","vomiting","abdominal pain","visual impairment","constipation","dyspnea","rash","cough"]"NA"{"encorafenib":"450 mg orally once daily","binimetinib":"45 mg orally twice daily"}2023-10-11https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-binimetinib-metastatic-non-small-cell-lung-cancer-braf-v600e-mutation
"Bosutinib (Bosulif, Pfizer)""NA""NA""NA""NA""NA""NA""Efficacy was evaluated in the BCHILD trial (NCT04258943), a multicenter, nonrandomized, open-label trial conducted to identify a recommended bosutinib dose in pediatric patients with ND CP Ph+ CML and R\/I CP Ph+ CML, to estimate the safety and tolerability and efficacy, and to evaluate bosutinib pharmacokinetics in this patient population."["Diarrhea","Abdominal pain","Vomiting","Nausea","Rash","Fatigue","Hepatic dysfunction","Headache","Pyrexia","Decreased appetite","Constipation"]"NA"{"ND CP Ph+ CML":"300 mg\/m^2 orally once daily with food","R\/I CP Ph+ CML":"400 mg\/m^2 orally once daily with food","Patients unable to swallow capsules":"The contents of the capsules can be mixed with applesauce or yogurt."}2023-09-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-bosutinib-pediatric-patients-chronic-myelogenous-leukemia
"Temozolomide (Temodar, Merck)""NA""NA""NA""NA""NA""NA""NA"["nausea","vomiting"]"Risk from exposure to opened capsules""Revised and updated regimen for newly diagnosed glioblastoma and refractory anaplastic astrocytoma"2023-09-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal
"HEPZATO KIT (melphalan for Injection\/Hepatic Delivery System)""36.3%""14 months""NA""NA""NA""NA""FOCUS study (NCT02678572), single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases."["Thrombocytopenia","Fatigue","Anemia","Nausea","Musculoskeletal pain","Leukopenia","Abdominal pain","Neutropenia","Vomiting","Increased alanine aminotransferase","Prolonged activated partial thromboplastin time","Increased aspartate aminotransferase","Increased blood alkaline phosphatase","Dyspnea"]"Severe peri-procedural complications (hemorrhage, hepatocellular injury, thromboembolic events) and myelosuppression resulting in severe infection, bleeding, or symptomatic anemia.""Melphalan dose of 3 mg\/kg based on ideal body weight, with a maximum dose of 220 mg during a single treatment. Administered via the Hepatic Delivery System (HDS) by infusion into the hepatic artery every 6 to 8 weeks for up to 6 total infusions."2023-08-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-melphalan-liver-directed-treatment-uveal-melanoma
"Elrexfio (elranatamab-bcmm) - Pfizer, Inc.""57.7%""Median DOR not reached (95% CI: 12 months, not reached)""NA""NA""NA""NA""MagnetisMM-3 (NCT04649359), ORR in 97 patients receiving recommended dose"["CRS","fatigue"]"Life-threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity"{"Step-up dose 1":"12 mg on Day 1","Step-up dose 2":"32 mg on Day 4","First treatment dose":"76 mg on Day 8","Maintenance dose":"76 mg weekly through week 24, then transition to every two weeks if response maintained"}2023-08-14https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma
"Akeega""NA""NA"{"BRCAm":{"Median":"16.6 months","HR":"0.53","p-value":"0.0014"},"Non-BRCA HRR mutations":{"HR":"0.99","95% CI":"0.67, 1.44"}}{"BRCAm":{"Median":"30.4 months","HR":"0.79","95% CI":"0.55, 1.12"},"Non-BRCA HRR mutations":{"HR":"1.13","95% CI":"0.77, 1.64"}}"NA""NA""Cohort 1 of MAGNITUDE trial (NCT03748641) with 423 patients."["Decreased hemoglobin","Decreased lymphocytes","Decreased white blood cells","Musculoskeletal pain","Fatigue","Decreased platelets","Increased alkaline phosphatase","Constipation","Hypertension","Nausea","Decreased neutrophils","Increased creatinine","Increased potassium","Decreased potassium","Increased AST"]"27% of patients required a blood transfusion.""200 mg niraparib + 1,000 mg abiraterone acetate orally once daily + 10 mg prednisone daily until disease progression or unacceptable toxicity."2023-08-11https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca-mutated-metastatic-castration
"null""null""null""null""null""null""null""null""null""null""null"2023-08-09https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma
"pralsetinib (Gavreto, Genentech, Inc.)"["78%","63%"]["13.4 months","38.8 months"]"NA""NA""NA""NA""Based on data from 237 patients with locally advanced or metastatic RET fusion-positive NSCLC"["musculoskeletal pain","constipation","hypertension","diarrhea","fatigue","edema","pyrexia","cough"]"NA""400 mg orally once daily"2023-08-09https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions
["trifluridine and tipiracil with bevacizumab, LONSURF"]"NA""NA"{"LONSURF plus bevacizumab":"5.6 months","LONSURF alone":"2.4 months","Hazard ratio":"0.44","p-value":"<0.001"}{"LONSURF plus bevacizumab":{"Median":"10.8 months","95% CI":"9.4, 11.8"},"LONSURF alone":{"Median":"7.5 months","95% CI":"6.3, 8.6"},"Hazard ratio":"0.61","p-value":"<0.001"}"NA""NA""SUNLIGHT (NCT04737187), randomized, open-label, multicenter, global trial of LONSURF with bevacizumab vs LONSURF in 492 mCRC patients"["neutropenia","anemia","thrombocytopenia","fatigue","nausea","increased AST","increased ALT","increased alkaline phosphatase","decreased sodium","diarrhea","abdominal pain","decreased appetite"]"NA""LONSURF dose is 35 mg\/m2 orally twice daily with food on days 1-5 and 8-12 of each 28-day cycle"2023-08-02https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-trifluridine-and-tipiracil-bevacizumab-previously-treated-metastatic-colorectal-cancer
"dostarlimab-gxly (Jemperli, GlaxoSmithKline)""NA""NA"{"dMMR\/MSI-H":{"dostarlimab-gxly with carboplatin and paclitaxel":"30.3 months","Placebo with carboplatin and paclitaxel":"7.7 months"}}"NA""NA""NA"{"Trial Name":"RUBY (NCT03981796)","Trial Type":"Randomized, multicenter, double-blind, placebo-controlled","Patient Subgroup":"122 patients with dMMR\/MSI-H primary advanced or recurrent EC","MMR\/MSI Testing":"Local testing assays (IHC, PCR, NGS) or central testing (IHC using Ventana MMR RxDx Panel)"}["Rash","Diarrhea","Hypothyroidism","Hypertension"]"NA"{"Starting Dose":"500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel","Maintenance Dose":"1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years","Administration":"Before chemotherapy when administered on the same day"}2023-07-31https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-dostarlimab-gxly-chemotherapy-endometrial-cancer
"quizartinib (Vanflyta, Daiichi Sankyo, Inc.)""NA""NA""NA"{"value":"Statistically significant improvement in OS for the quizartinib arm","hazard ratio":0.78,"95% CI":[0.62,0.98],"p-value":0.0324}{"Quizartinib arm":{"CR rate":"55%","Median duration":"38.6 months"},"Placebo arm":{"CR rate":"55%","Median duration":"12.4 months"}}"NA"{"Trial name":"QuANTUM-First","Trial ID":"NCT02668653","Trial design":"Randomized, double-blind, placebo-controlled trial","Number of patients":539,"FLT3-ITD status determination":"Prospectively with a clinical trial assay and verified retrospectively with LeukoStrat CDx FLT3 Mutation Assay"}["QT prolongation","Torsades de pointes"]"QT prolongation, torsades de pointes, and cardiac arrest"{"Induction":"35.4 mg orally once daily on specific days","Consolidation":"35.4 mg orally once daily on specific days","Maintenance":"26.5 mg orally once daily for certain days, then 53 mg once daily thereafter"}2023-07-20https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia
"talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide""NA""NA""rPFS""NA""NA""NA""TALAPRO-2 (NCT03395197)"["decreased hemoglobin","decreased neutrophils","decreased lymphocytes","fatigue","decreased platelets","decreased calcium","nausea","decreased appetite","decreased sodium","decreased phosphate","fractures","decreased magnesium","dizziness","increased bilirubin","decreased potassium","dysgeusia"]"39% patients required a blood transfusion, 22% required multiple transfusions, 2 patients were diagnosed with myelodysplastic syndrome\/acute myeloid leukemia (MDS\/AML)""talazoparib 0.5 mg with enzalutamide 160 mg orally once daily"2023-06-20https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate
"null""null""null""null""null""null""null""null""null""null""null"2023-06-16https://fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell
"null""null""null""null""null""null""null""null""null""null""null"2023-05-31https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-abiraterone-and-prednisone-or-prednisolone-brca-mutated-metastatic-castration
"Epcoritamab-bysp (Epkinly)""61%""15.6 months""NA""NA""38%""NA""EPCORE NHL-1 (NCT03625037), open-label, multi-cohort, multicenter, single-arm trial in patients with relapsed or refractory B-cell lymphoma"["CRS","fatigue"]"Serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS)""Step-up dosing in Cycle 1 (0.16 mg on Day 1, 0.8 mg on Day 8, and 48 mg on Day 15 and Day 22) followed by fixed dosing of 48 mg weekly dosing during Cycles 2 through 3, every other week during Cycle 4 through 9, and then every four weeks on Day 1 of subsequent cycles"2023-05-19https://fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell
"polatuzumab vedotin-piiq (Polivy, Genentech, Inc.)""NA""NA""0.73 (95% CI: 0.57, 0.95; p = 0.0177)""HR 0.94; 95% CI: 0.67, 1.33 on final analysis""NA""NA""POLARIX (NCT03274492) - randomized, double-blind, placebo-controlled trial in 879 patients with previously untreated large B-cell lymphoma and IPI score of 2-5"["peripheral neuropathy","nausea","fatigue","diarrhea","constipation","alopecia","mucositis"]"Grade 3 to 4 laboratory abnormalities (\u226510%) were lymphopenia, neutropenia, hyperuricemia, and anemia. Peripheral neuropathy developed or worsened in 53% of patients.""1.8 mg\/kg as an intravenous infusion every 21 days for 6 cycles in combination with R-CHP"2023-04-19https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not
"Omisirge (omidubicel-onlv)""NA""NA""NA""NA""NA""NA"{"Trial Name":"Study P0501","Trial ID":"NCT02730299","Patient Population":"Adult and pediatric patients (12 years and older) with hematologic malignancies planned for umbilical cord blood transplantation","Interventions":{"Omisirge Arm":{"Patients":62,"CD34+ Cell Dose Range":"2.1 \u2013 47.6 X 10^6 cells\/kg","Median Time to Neutrophil Recovery":"12 days (95% CI: 10-15 days)","Infections Through Day 100":{"BMT CTN Grade 2\/3 bacterial":"39%","BMT CTN Grade 3 fungal":"60%"},"Adverse Reactions":{"Pain":"33%","Mucosal Inflammation":"31%","Hypertension":"25%","Gastrointestinal Toxicity":"19%"}},"UCB Arm":{"Patients":63,"CD34+ Cell Dose Range":"0.0 \u2013 0.8 X 10^6 cells\/kg","Median Time to Neutrophil Recovery":"22 days (95% CI: 19-25 days)"}}}["Pain","Mucosal Inflammation","Hypertension","Gastrointestinal Toxicity"]{"Boxed Warning":["Fatal or life-threatening infusion reactions","GvHD","Engraftment syndrome","Graft failure"],"Adverse Events":{"Omidubicel-onlv Patients":{"Infusion Reactions":"47%","Acute GVHD":"58%","Chronic GvHD":"35%","Graft Failure":"3%"}}}{"Cultured Fraction":{"Total Viable Cells":"8.0 \u00d7 10^8","Minimum CD34+ Cells":"8.7%","Total CD34+ Cells":"9.2 \u00d7 10^7"},"Non-cultured Fraction":{"Total Viable Cells":"4.0 \u00d7 10^8","CD3+ Cells":"2.4 \u00d7 10^7"}}2023-04-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-omidubicel-reduce-time-neutrophil-recovery-and-infection-patients-hematologic
["Padcev","Keytruda"]"68%""22 months (range: 1+ to 46+)""NA""NA""12%""NA""EV-103\/KEYNOTE-869 (NCT03288545), dose escalation cohort, Cohort A, Cohort K"["increased glucose","increased aspartate aminotransferase","rash","decreased hemoglobin","increased creatinine","peripheral neuropathy","decreased lymphocytes","fatigue","increased alanine aminotransferase","decreased sodium","increased lipase","decreased albumin","alopecia","decreased phosphate","decreased weight","diarrhea","pruritus","decreased appetite","nausea","dysgeusia","decreased potassium","decreased neutrophils","urinary tract infection","constipation","potassium increased","calcium increased","peripheral edema","dry eye","dizziness","arthralgia","dry skin"]"NA"{"enfortumab vedotin-ejfv":"1.25 mg\/kg (up to a maximum of 125 mg for patients \u2265100 kg) administered as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity","pembrolizumab":"200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months"}2023-04-03https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic
"null""null""null""null""null""null""null""null""null""null""null"2023-03-22https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel
["dabrafenib (Tafinlar, Novartis)","trametinib (Mekinist, Novartis)"]"46.6%"{"D+T":"23.7 months","C+V":"Not estimable"}{"D+T":"20.1 months","C+V":"7.4 months"}{"D+T":"Results not reached statistical significance","C+V":"Results not reached statistical significance"}"NA""NA"{"Trial name":"Study CDRB436G2201 (NCT02684058)","Patient cohort":"LGG grade 1 and 2 with BRAF V600E mutation","Treatment arms":{"D+T":"73 patients","C+V":"37 patients"}}["Pyrexia (66%)","Rash (54%)"]"NA"{"Dabrafenib":"Administered orally twice daily based on body weight","Trametinib":"Administered orally once daily based on body weight"}2023-03-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation
"abemaciclib (Verzenio, Eli Lilly and Company)""NA""NA""IDFS at 48 months: 85.5% (abemaciclib plus standard endocrine therapy) vs. 78.6% (standard endocrine therapy alone)""NA""NA""NA""monarchE (NCT03155997) - randomized, open-label, two-cohort multicenter trial"["diarrhea","infections","neutropenia","fatigue","leukopenia","nausea","anemia","headache"]"More deaths observed in cohort 2 with abemaciclib plus standard endocrine therapy compared to standard endocrine therapy alone""150 mg taken twice daily with endocrine therapy for 2 years or until disease recurrence or unacceptable toxicity"2023-03-03https://fda.gov/drugs/resources-information-approved-drugs/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy
"null""null""null""null""null""null""null""null""null""null""null"2023-02-09https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-dostarlimab-gxly-dmmr-endometrial-cancer
"sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.)""NA""NA""5.5 months (95% CI: 4.2, 7.0)""14.4 months for sacituzumab govitecan-hziy (95% CI: 13.0, 15.7)""NA""NA"{"Study Name":"TROPiCS-02 (NCT03901339)","Number of patients":543,"Study Design":"multicenter, open label, randomized study","Treatment Arms":{"Sacituzumab Govitecan-hziy Arm":{"Dosage":"10 mg\/kg as an intravenous infusion on Days 1 and 8 of a 21-day cycle","Number of Patients":272},"Single Agent Chemotherapy Arm":{"Options":["eribulin (n=130)","vinorelbine (n=63)","gemcitabine (n=56)","capecitabine (n=22)"],"Number of Patients":271}}}["decreased leukocyte count (88%)","diarrhea (62%)"]"NA""10 mg\/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity"2023-02-03https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer
"elacestrant (Orserdu, Stemline Therapeutics, Inc.)""NA""NA"{"Patients with ESR1 mutations":{"Elacestrant arm":{"Median PFS":"3.8 months (95% CI: 2.2, 7.3)","Hazard ratio (HR)":"0.55 (95% CI: 0.39, 0.77)","P-value":"0.0005"},"Fulvestrant or aromatase inhibitor arm":{"Median PFS":"1.9 months (95% CI: 1.9, 2.1)"}},"Patients without ESR1 mutations":{"HR":"0.86 (95% CI: 0.63, 1.19)"}}"NA""NA""NA"{"Trial acronym":"EMERALD","Trial number":"NCT03778931","Design":"Randomized, open-label, active-controlled, multicenter trial","Eligibility criteria":"Postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer"}["Musculoskeletal pain","Nausea","Increased cholesterol","Increased AST","Increased triglycerides","Fatigue","Decreased hemoglobin","Vomiting","Increased ALT","Decreased sodium","Increased creatinine","Decreased appetite","Diarrhea","Headache","Constipation","Abdominal pain","Hot flush","Dyspepsia"]"NA""345 mg orally once daily with food until disease progression or unacceptable toxicity"2023-01-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer
"pirtobrutinib (Jaypirca, Eli Lilly and Company)""50%""8.3 months""NA""NA""13%""NA""BRUIN (NCT03740529), open-label, multicenter, single-arm trial of pirtobrutinib monotherapy with 120 MCL patients previously treated with a BTK inhibitor"["Fatigue","Musculoskeletal pain"]"Warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies""200 mg orally once daily until disease progression or unacceptable toxicity"2023-01-27https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma
"pembrolizumab (Keytruda, Merck)""NA""NA""NA""NA""NA""NA"{"Trial name":"KEYNOTE-091 (NCT02504372)","Trial type":"Multicenter, randomized, triple-blind, placebo-controlled trial","Population":"Patients with stage IB (T2a \u22654 cm), II, or IIIA non-small cell lung cancer (NSCLC) who had not received neoadjuvant radiotherapy or chemotherapy","Treatment arms":{"Arm 1":{"Treatment":"Pembrolizumab 200 mg intravenously every 3 weeks","Number of patients":"NA"},"Arm 2":{"Treatment":"Placebo intravenously every 3 weeks","Number of patients":"NA"}}}["Hypothyroidism (22%)","Hyperthyroidism (11%)","Pneumonitis (7%)"]"Two fatal adverse reactions of myocarditis occurred""200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months"2023-01-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-non-small-cell-lung-cancer
"zanubrutinib""80%""Not provided""Not provided""Not provided""NA""NA"{"Treatment-na\u00efve CLL\/SLL":{"Trial":"SEQUOIA (NCT03336333)","Randomized cohort":"479 patients","Comparison arms":"zanubrutinib vs. bendamustine plus rituximab (BR)","Main outcome measure":"PFS","Data":{"Zanubrutinib arm":{"Median PFS":"Not reached","HR":"0.42"},"BR arm":{"Median PFS":"33.7 months"}}},"Relapsed or refractory CLL\/SLL":{"Trial":"ALPINE (NCT03734016)","Randomized cohort":"652 patients","Comparison arms":"zanubrutinib vs. ibrutinib","Main outcome measures":"ORR and DOR","Data":{"Zanubrutinib arm":{"ORR":"80%"},"Ibrutinib arm":{"ORR":"73%"}}}}["Neutrophil count decreased","Upper respiratory tract infection","Platelet count decreased","Hemorrhage","Musculoskeletal pain"]["Second primary malignancies reported in 13% of patients","Atrial fibrillation or flutter in 3.7% of patients","Grade 3 or higher ventricular arrhythmias in 0.2% of patients"]"160 mg taken orally twice daily or 320 mg taken orally once daily"2023-01-19https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma
"Tukysa""38%""12.4 months""NA""NA""NA""NA"{"Trial Name":"MOUNTAINEER (NCT03043313)","Patient Population":"HER2-positive, RAS wild-type, unresectable or metastatic colorectal cancer","Prior Treatment":"Fluoropyrimidine, oxaliplatin, irinotecan, and an anti-VEGF monoclonal antibody"}["Diarrhea","Fatigue","Rash","Nausea","Abdominal Pain","Infusion related reactions","Pyrexia"]{"Common laboratory abnormalities":["Increased creatinine","Increased glucose","Increased ALT","Decreased hemoglobin","Increased AST","Increased bilirubin","Increased alkaline phosphatase","Decreased lymphocytes","Decreased albumin","Decreased leukocytes","Decreased sodium"]}"Tucatinib 300 mg orally twice daily in combination with trastuzumab"2023-01-19https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tucatinib-trastuzumab-colorectal-cancer
"null""null""null""null""null""null""null""null""null""null""null"2022-12-23https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mosunetuzumab-axgb-relapsed-or-refractory-follicular-lymphoma
"nadofaragene firadenovec-vncg (Adstiladrin)""NA""9.7 months""NA""NA""51%""NA""Study CS-003 (NCT02773849), a multicenter, single-arm trial enrolling 157 patients with high-risk NMIBC"["increased glucose","instillation site discharge","increased triglycerides","fatigue","bladder spasm","micturition urgency","increased creatinine","hematuria","decreased phosphate","chills","dysuria","pyrexia"]"NA""75 mL at a concentration of 3 x 10^11 viral particles\/mL instilled once every three months into the bladder via a urinary catheter. Premedication with an anticholinergic is recommended prior to each instillation."2022-12-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin
"capecitabine tablets (Xeloda, Genentech, Inc.)""NA""NA""NA""NA""NA""NA""NA"["NA","NA"]"NA""Recommended capecitabine dose depends on the indication."2022-12-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine
"adagrasib (Krazati, Mirati Therapeutics, Inc.)""43%""8.5 months""NA""NA""NA""NA""KRYSTAL-1, a multicenter, single-arm, open-label clinical trial (NCT03785249) in patients with locally advanced or metastatic NSCLC with KRAS G12C mutations"["diarrhea","nausea","fatigue","vomiting","musculoskeletal pain","hepatotoxicity","renal impairment","dyspnea","edema","decreased appetite","cough","pneumonia","dizziness","constipation","abdominal pain","QTc interval prolongation"]"NA""600 mg orally twice daily until disease progression or unacceptable toxicity"2022-12-12https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc
"atezolizumab (Tecentriq, Genentech, Inc.)""24%""67% had a DOR of 6 months or more, 42% had a DOR of 12 months or more""NA""NA""NA""NA""Study ML39345 (NCT03141684), open-label, single-arm study in 49 adult and pediatric patients with unresectable or metastatic ASPS"["musculoskeletal pain (67%)","fatigue (55%)"]"NA""For adult patients: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. For pediatric patients 2 years of age and older: 15 mg\/kg every 3 weeks"2022-12-09https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-approval-atezolizumab-alveolar-soft-part-sarcoma
"olutasidenib (Rezlidhia)""35%""25.9 months""NA""NA""32%""2.7%""Study 2102-HEM-101 (NCT02719574), 147 adult patients with relapsed or refractory AML with IDH1 mutation"["nausea","fatigue\/malaise","arthralgia","constipation","leukocytosis","dyspnea","fever","rash","mucositis","diarrhea","transaminitis"]"Differentiation syndrome - Boxed Warning""150 mg oral twice daily on an empty stomach"2022-12-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-olutasidenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-idh1-mutation
"Rylaze""NA""NA""NA""NA""NA""NA""The determination of efficacy was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U\/mL by simulation in a virtual population."["neutropenia","anemia","thrombocytopenia"]"All patients treated with the recommended dosages of Rylaze as a component of multi-agent chemotherapy experienced various adverse reactions including abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.""Patients should receive 25 mg\/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg\/m2 intramuscularly on Friday afternoon. It is also approved to be administered every 48 hours at a dose of 25 mg\/m2 intramuscularly."2022-11-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-asparaginase-erwinia-chrysanthemi-recombinant
"mirvetuximab soravtansine-gynx""31.7%""6.9 months""NA""NA""NA""NA""Study 0417 (NCT04296890), a single-arm trial of 106 patients with FR\u03b1 positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer"["vision impairment","fatigue","increased aspartate aminotransferase","nausea","increased alanine aminotransferase","keratopathy","abdominal pain","decreased lymphocytes","peripheral neuropathy","diarrhea","decreased albumin","constipation","increased alkaline phosphatase","dry eye","decreased magnesium","decreased leukocytes","decreased neutrophils","decreased hemoglobin"]"Ocular toxicity (boxed warning)""6 mg\/kg adjusted ideal body weight (AIBW) administered once every three weeks as an intravenous infusion until disease progression or unacceptable toxicity"2022-11-14https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant
["tremelimumab (Imjudo)","durvalumab (Imfinzi)"]["39%","24%"]["9.5 months","5.1 months"]["6.2 months","4.8 months"]["14 months","11.7 months"]"NA""NA""POSEIDON (NCT03164616), randomized (1:1:1), multicenter, active-controlled, open-label study"["nausea","fatigue","decreased appetite","musculoskeletal pain","rash","diarrhea"]"Grade 3 or 4 laboratory abnormalities (\u2265 10%) were neutropenia, anemia, leukopenia, lymphocytopenia, lipase increased, hyponatremia, and thrombocytopenia."{"Patients weighing 30 kg or more":{"tremelimumab dose":"75 mg IV every 3 weeks","durvalumab dose":"1500 mg IV","platinum-based chemotherapy cycles":4,"maintenance chemotherapy frequency":"4 weeks","additional dosing":"Fifth tremelimumab dose (75 mg) at week 16"},"Patients weighing less than 30 kg":{"tremelimumab dose":"1 mg\/kg","durvalumab dose":"20 mg\/kg"}}2022-11-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non
"brentuximab vedotin (Adcetris, Seagen, Inc.)""NA""NA""Median EFS was not reached in either arm.""NA""NA""NA""Efficacy was evaluated in a randomized, open-label, actively controlled trial with high-risk classical Hodgkin lymphoma patients. The main efficacy outcome measure was event-free survival with a corresponding hazard ratio of 0.41 (95% CI: 0.25, 0.67; p=0.0002)"["neutropenia","febrile neutropenia","anemia","thrombocytopenia","stomatitis","infection"]"NA""The recommended brentuximab vedotin dose for pediatric patients 2 years of age and older is 1.8 mg\/kg up to a maximum of 180 mg in combination with AVEPC every 3 weeks for a maximum of 5 doses."2022-11-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-combination-chemotherapy-pediatric-patients-classical-hodgkin
["cemiplimab-rwlc"]"43%""Not provided"{"cemiplimab-rwlc plus chemotherapy":"8.2 months","placebo plus chemotherapy":"5.0 months"}{"cemiplimab-rwlc plus chemotherapy":"21.9 months","placebo plus chemotherapy":"13.0 months"}"NA""NA"{"Study ID":"16113","Study Type":"Randomized, multicenter, double-blind","Patient Count":"466","Treatments":[{"Treatment":"Cemiplimab-rwlc plus platinum-based chemotherapy","Frequency":"Every 3 weeks for 4 cycles followed by maintenance","Outcome Measures":["OS","PFS","ORR"]},{"Treatment":"Placebo plus platinum-based chemotherapy","Frequency":"Every 3 weeks for 4 cycles followed by maintenance","Outcome Measures":["OS","PFS","ORR"]}]}["alopecia","musculoskeletal pain","nausea","fatigue","peripheral neuropathy","decreased appetite"]"Not provided""350 mg IV every 3 weeks"2022-11-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer
"null""null""null""null""null""null""null""null""null""null""null"2022-10-25https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma
"null""null""null""null""null""null""null""null""null""null""null"2022-10-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-unresectable-hepatocellular-carcinoma
"futibatinib (Lytgobi, Taiho Oncology, Inc.)""42%""9.7 months""NA""NA""NA""All 43 responders achieved partial responses""TAS-120-101 (NCT02052778), a multicenter, open-label, single-arm trial that enrolled 103 patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring a FGFR2 gene fusion or other rearrangement"["nail toxicity","musculoskeletal pain","constipation","diarrhea","fatigue","dry mouth","alopecia","stomatitis","abdominal pain","dry skin","arthralgia","dysgeusia","dry eye","nausea","decreased appetite","urinary tract infection","palmar-plantar erythrodysesthesia syndrome","vomiting"]"NA""20 mg orally once daily until disease progression or unacceptable toxicity occurs"2022-09-30https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma
"selpercatinib""61% in previously treated patients""28.6 months in previously treated patients""NA""NA""NA""NA"{"Total patients":316,"Primary efficacy measures":{"Treatment-na\u00efve patients":{"ORR":"84%","DOR":"20.2 months"},"Previously treated patients":{"ORR":"61%","DOR":"28.6 months"}},"Demographics":{"Median age":"61 years","Gender":{"Female":"58%","Male":"42%"},"Race":{"White":"49%","Asian":"41%","Black":"5%"},"ECOG performance status":"97% had ECOG 0 or 1","Metastatic disease":"97%","Prior treatments":{"Median prior systemic therapies":2,"Prior anti PD 1\/PD-L1 therapy":"58%"}}}["Edema","Diarrhea","Fatigue","Dry mouth","Hypertension","Abdominal pain","Constipation","Rash","Nausea","Headache"]"NA"{"Less than 50 kg":"120 mg orally twice daily","50 kg or greater":"160 mg orally twice daily"}2022-09-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung
"selpercatinib (Retevmo, Eli Lilly and Company)""44%""24.5 months""NA""NA""NA""NA""LIBRETTO-001 (NCT03157128), 41 patients with RET fusion-positive tumors"["edema","diarrhea","fatigue","dry mouth","hypertension","abdominal pain","constipation","rash","nausea","headache"]"NA"{"Less than 50 kg":"120 mg orally twice daily","50 kg or greater":"160 mg orally twice daily"}2022-09-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-solid-tumors
"sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.)""NA""NA""NA""NA""NA""NA""Efficacy was evaluated in two multicenter open-label, randomized controlled trials in pediatric patients undergoing treatment with cisplatin-based chemotherapy for cancer: SIOPEL 6 (NCT00652132) and COG ACCL0431 (NCT00716976)."["vomiting","nausea","decreased hemoglobin","hypernatremia","hypokalemia"]"Substitutions pose potential health risks, including potassium chloride exposure, overexposure to boric acid, and overexposure to sodium nitrite.""The recommended sodium thiosulfate dose is based on surface area according to actual body weight. Sodium thiosulfate is administered as an intravenous infusion over 15 minutes following cisplatin infusions that are 1 to 6 hours in duration."2022-09-20https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-sodium-thiosulfate-reduce-risk-ototoxicity-associated-cisplatin-pediatric-patients
"durvalumab (Imfinzi, AstraZeneca UK Limited)""27% (95% CI: 22% - 32%)""NA"{"durvalumab":"7.2 months (95% CI: 6.7, 7.4)","placebo":"5.7 months (95% CI: 5.6, 6.7)"}{"durvalumab":"12.8 months (95% CI: 11.1, 14)","placebo":"11.5 months (95% CI: 10.1, 12.5)"}"NA""NA""TOPAZ-1 (NCT03875235), a randomized, double-blind, placebo-controlled, multiregional trial of 685 patients"["fatigue","nausea","constipation","decreased appetite","abdominal pain","rash","pyrexia"]"NA"{"body weight>=30 kg":"1,500 mg every 3 weeks with gemcitabine and cisplatin, followed by 1,500 mg every 4 weeks as a single agent","body weight<30 kg":"20 mg\/kg every 3 weeks with gemcitabine and cisplatin, followed by 20 mg\/kg every 4 weeks"}2022-09-02https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-locally-advanced-or-metastatic-biliary-tract-cancer
"pemigatinib (Pemazyre, Incyte Corporation)""NA""NA""NA""NA""78%""NA""FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial including 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement."["hyperphosphatemia","nail toxicity","alopecia","stomatitis","diarrhea","dry eye","fatigue","rash","abdominal pain","anemia","constipation","dry mouth","epistaxis","serous retinal detachment","extremity pain","decreased appetite","dry skin","dyspepsia","back pain","nausea","blurred vision","peripheral edema","dizziness"]"NA""13.5 mg orally once daily on a continuous basis until disease progression or unacceptable toxicity"2022-08-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pemigatinib-relapsed-or-refractory-myeloidlymphoid-neoplasms-fgfr1-rearrangement
"ibrutinib (Imbruvica, Pharmacyclics LLC)""60%""5.3 months""NA""NA""NA""NA""iMAGINE (NCT03790332) trial of ibrutinib for pediatric and young adult patients with cGVHD"["anemia","musculoskeletal pain","pyrexia","diarrhea","pneumonia","abdominal pain","stomatitis","thrombocytopenia","headache"]"NA"{"Patients 12 years and older":"420 mg orally once daily","Patients 1 to less than 12 years":"240 mg\/m2 orally once daily (up to a dose of 420 mg)"}2022-08-24https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ibrutinib-pediatric-patients-chronic-graft-versus-host-disease-including-new-oral
"Enhertu"588.7"NA""NA""NA""NA""DESTINY-Lung02, a multicenter, multi-cohort, randomized, blinded, dose-optimization trial"["nausea","decreased white blood cell count","decreased hemoglobin","decreased neutrophil count","decreased lymphocyte count","decreased platelet count","decreased albumin","increased aspartate aminotransferase","increased alanine aminotransferase","fatigue","constipation","decreased appetite","vomiting","increased alkaline phosphatase","alopecia"]"Risk of interstitial lung disease and embryo-fetal toxicity""5.4 mg\/kg given intravenously every 3 weeks"2022-08-11https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung
"Capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.)"{"treatment_naive_patients":"68%","previously_treated_patients":"44%"}{"treatment_naive_patients":"16.6 months","previously_treated_patients":"9.7 months"}"NA""NA""NA""NA"[{"study_name":"GEOMETRY mono-1 trial","trial_id":"NCT02414139","study_design":"multicenter, non-randomized, open-label, multi-cohort study","additional_data":"data from 63 additional patients and 22 months of follow-up"}]["edema","nausea","musculoskeletal pain","fatigue","vomiting","dyspnea","cough","decreased appetite"]"NA""400 mg orally twice daily with or without food"2022-08-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-capmatinib-metastatic-non-small-cell-lung-cancer
["darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.)","docetaxel"]"NA""NA""NA""Median OS was not reached (NR) in the darolutamide plus docetaxel arm and 48.9 months in the docetaxel plus placebo arm""NA""NA""Based on ARASENS (NCT02799602) trial in 1306 patients with metastatic hormone-sensitive prostate cancer. Darolutamide plus docetaxel showed a statistically significant delay in time-to-pain progression."["constipation","decreased appetite","rash","hemorrhage","increased weight","hypertension"]"NA""Darolutamide 600 mg orally twice daily with food; Docetaxel 75 mg\/m2 intravenously every 3 weeks for up to 6 cycles."2022-08-05https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-tablets-metastatic-hormone-sensitive-prostate-cancer
"Enhertu""NA""NA"{"HR+":{"Enhertu":10.1,"Chemotherapy":5.4},"Overall":{"Enhertu":9.9,"Chemotherapy":5.1}}{"HR+":{"Enhertu":23.9,"Chemotherapy":17.5},"Overall":{"Enhertu":23.4,"Chemotherapy":16.8}}"NA""NA"{"Study":"DESTINY-Breast04","Total patients":557,"Cohorts":{"HR+":494,"HR-":63},"Definition of HER2-low":"IHC 1+ or IHC 2+\/ISH-","Randomization":{"Enhertu":373,"Chemotherapy":184}}["nausea","fatigue","alopecia","vomiting","anemia","constipation","decreased appetite","diarrhea","musculoskeletal pain"]["Interstitial lung disease","Embryo-fetal toxicity"]"5.4 mg\/kg given as an intravenous infusion once every 3 weeks"2022-08-05https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer
"Crizotinib (Xalkori, Pfizer Inc.)"{"Pediatric patients":"86%","Adult patients":"71%"}"NA""NA""NA""NA""NA"{"Pediatric patients":"14 patients from trial ADVL0912","Adult patients":"7 patients from trial A8081013"}["vomiting","nausea","diarrhea","abdominal pain","vision disorder","edema","constipation","headache"]"NA"{"Adult patients":"250 mg orally twice daily until disease progression or unacceptable toxicity","Pediatric patients":"280 mg\/m2 orally twice daily until disease progression or unacceptable toxicity"}2022-07-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-crizotinib-alk-positive-inflammatory-myofibroblastic-tumor
"lisocabtagene maraleucel (Breyanzi)""NA""NA"{"lisocabtagene maraleucel arm":{"HR":0.41,"95% CI":[0.25,0.66],"p-value":0.0001}}"NA"{"TRANSFORM trial":{"Rate":"NA","Median DOR":"NA"},"PILOT trial":{"Rate":"54%","Median DOR (CR)":"not reached","Median DOR (PR)":"2.1 months","CR rate among all leukapheresed patients":"46%"}}"NA"{"TRANSFORM trial":{"Study design":"randomized, open-label, multicenter trial","Number of patients":184,"EFS HR":0.34,"95% CI":[0.22,0.52],"p-value":"<0.0001","1-year EFS":{"lisocabtagene maraleucel arm":"45%","standard therapy arm":"24%"},"Estimated median EFS":{"lisocabtagene maraleucel arm":"10.1 months","standard therapy arm":"2.3 months"}},"PILOT trial":{"Study design":"single-arm, open-label, multicenter trial","Number of patients":74,"CR rate":"54%","PR rate":"NA","Median DOR (CR)":"not reached","Median DOR (PR)":"2.1 months","CR rate among all leukapheresed patients":"46%"}}[{"Adverse reaction":"Cytokine Release Syndrome (CRS)","Incidence":"45%","Grade 3 or higher":"1.3%"},{"Adverse reaction":"Neurologic toxicities","Incidence":"27%","Grade 3":"7%"}]"Risk of fatal or life-threatening CRS and neurologic toxicities""90 to 110 \u00d7 10^6 CAR-positive T cells with a 1:1 ratio of CD4 and CD8 components"2022-06-24https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-second-line-treatment-large-b-cell-lymphoma
["dabrafenib (Tafinlar, Novartis)","trametinib (Mekinist, Novartis)"]{"adult":"41% (95% CI: 33, 50)","pediatric":"25% (95% CI: 12, 42)"}{"adult":{"\u22656 months":"78%","\u226524 months":"44%"},"pediatric":"NA"}"NA""NA""NA""NA"{"Study BRF117019 (NCT02034110)":"131 adult patients with BRAF V600E mutation","NCI-MATCH (NCT02465060)":"adult patients with BRAF V600E mutation solid tumors except melanoma, thyroid cancer, or CRC","CTMT212X2101 (NCT02124772)":"36 pediatric patients with BRAF V600 refractory or recurrent LGG or HGG"}["pyrexia","fatigue","nausea","rash","chills","headache","hemorrhage","cough","vomiting","constipation","diarrhea","myalgia","arthralgia","edema"]"NA"{"adult patients":{"dabrafenib":"150 mg orally twice daily","trametinib":"2 mg orally once daily"},"pediatric patients":"based on body weight"}2022-06-22https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dabrafenib-combination-trametinib-unresectable-or-metastatic-solid
"Kymriah""86%""Not reached, 75% responders still in response at 9 months""NA""NA""68%""NA""ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial"["Cytokine release syndrome","Infection","Fatigue","Musculoskeletal pain","Headache","Diarrhea"]"NA""0.6 to 6.0 x 108 CAR-positive viable T cells"2022-05-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisagenlecleucel-relapsed-or-refractory-follicular-lymphoma
"nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy, nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company)""NA""NA""NA"{"ITT population":{"nivolumab, fluorouracil, and cisplatin vs. chemotherapy":{"HR":0.74,"95% CI":"0.61, 0.90","p-value":0.0021},"nivolumab and ipilimumab vs. chemotherapy":{"HR":0.78,"95% CI":"0.65, 0.95","p-value":0.011},"Median OS":{"nivolumab, fluorouracil, and cisplatin":"13.2 months (95% CI: 11.1, 15.7)","nivolumab and ipilimumab":"12.8 months (95% CI: 11.3, 15.5)","fluorouracil and cisplatin":"10.7 months (95% CI: 9.4, 11.9)"}},"TC PD-L1 \u22651% population":{"nivolumab, fluorouracil, and cisplatin vs. chemotherapy":{"HR":0.54,"95% CI":"0.41, 0.71","p-value":"<0.0001"},"nivolumab and ipilimumab vs. chemotherapy":{"HR":0.64,"95% CI":"0.49, 0.84","p-value":0.001}}}"NA""NA"{"Trial":"CHECKMATE-648 (NCT03143153)","Population":"970 patients with previously untreated unresectable advanced, recurrent or metastatic ESCC","Treatment arms":{"Arm 1":"nivolumab 240 mg + fluorouracil + cisplatin","Arm 2":"nivolumab 3 mg\/kg + ipilimumab 1 mg\/kg","Arm 3":"fluorouracil + cisplatin"},"Major outcome measures":{"OS":"Overall Survival","PFS":"Progression-Free Survival"}}["nausea","fatigue","constipation","diarrhea"]"NA"{"nivolumab with chemotherapy":{"Dosage 1":"240 mg every 2 weeks","Dosage 2":"480 mg every 4 weeks"},"nivolumab with ipilimumab":{"Dosage":"3 mg\/kg every 2 weeks or 360 mg every 3 weeks with ipilimumab 1 mg\/kg every 6 weeks"}}2022-05-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdivo-combination-chemotherapy-and-opdivo-combination-yervoy-first-line-esophageal
"Ivosidenib (Tibsovo)""NA""NA""NA"{"Ivosidenib plus Azacitidine arm":"24.0 months (95% CI: 11.3, 34.1)","Placebo plus Azacitidine arm":"7.9 months (95% CI: 4.1, 11.3)"}{"Ivosidenib plus Azacitidine arm":"47% (95% CI: 35%, 59%)","Placebo plus Azacitidine arm":"15% (95% CI: 8%, 25%)"}"NA"{"Study name":"AG120-C-009","Trial ID":"NCT03173248","Patient count":146,"Criteria for inclusion":["Age 75 years or older","Baseline ECOG performance status of 2","Severe cardiac or pulmonary disease","Hepatic impairment with bilirubin > 1.5 times the upper limit of normal","Creatinine clearance < 45 mL\/min","Other comorbidity"],"Treatment arms":{"Ivosidenib + Azacitidine":{"Patient count":72,"Dosage":"Ivosidenib 500 mg daily","Route of administration":"Orally once daily","Duration":"Days 1-28 in each 28-day cycle"},"Placebo + Azacitidine":{"Patient count":74,"Dosage":"Matched placebo orally once daily","Route of administration":"Orally once daily","Duration":"Days 1-28 in each 28-day cycle"}}}["Diarrhea","Fatigue","Edema","Nausea","Vomiting","Decreased appetite","Leukocytosis","Arthralgia","Dyspnea","Abdominal pain","Mucositis","Rash","Electrocardiogram QT prolonged","Differentiation syndrome","Myalgia"]"Differentiation syndrome - life-threatening or fatal"{"Ivosidenib":"500 mg taken orally once daily with or without food until disease progression or unacceptable toxicity","Azacitidine":"75 mg\/m2\/day subcutaneously or intravenously on Days 1-7 or Days 1-5 and 8-9 of each 28-day cycle"}2022-05-25https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-combination-azacitidine-newly-diagnosed-acute-myeloid-leukemia
"azacitidine (Vidaza, Celgene Corp.)""50%""NA""NA""NA""3""6""AZA-JMML-001 (NCT02447666)"["pyrexia","rash","upper respiratory tract infection","anemia"]"NA"{"1 month to less than 1 year of age or weighing less than 10 kg":"2.5 mg\/kg","Patients \u2265 age 1 and weighing \u2265 10 kg":"75 mg\/m2"}2022-05-20https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-azacitidine-newly-diagnosed-juvenile-myelomonocytic-leukemia
["fam-trastuzumab deruxtecan-nxki"]"82.7%""NA""not reached""OS was immature""NA""NA""DESTINY-Breast03 (NCT03529110)"["nausea","fatigue","vomiting","alopecia","constipation","anemia","musculoskeletal pain"]["interstitial lung disease","embryo-fetal toxicity"]"5.4 mg\/kg given as an intravenous infusion once every 3 weeks"2022-05-04https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer
"alpelisib (Vijoice, Novartis Pharmaceuticals)""27%""60% had a response lasting 12 months or longer""NA""NA""NA""NA""Efficacy evaluated in 37 patients with at least one target lesion identified on imaging within 24 weeks."["diarrhea","stomatitis","hyperglycemia"]"NA"{"Pediatric patients (2 to less than 18 years)":"50 mg OR 125 mg after 24 weeks if clinically indicated","Adult patients (\u2265 18 years)":"250 mg"}2022-04-06https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-alpelisib-pik3ca-related-overgrowth-spectrum
"axicabtagene ciloleucel""83%""8.3 months""8.3 months""Not provided""NA""NA""ZUMA-7 trial with 359 patients randomized 1:1 to receive axicabtagene ciloleucel or standard therapy"["Cytokine release syndrome (90%)","Neurologic toxicities (78%)"]"Not provided""2 x 10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum of 2 x 10^8 CAR-positive viable T cells"2022-04-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma
["Pluvicto","Locametz"]"NA""NA""rPFS""OS""NA""NA"{"Trial Identifier":"VISION (NCT03511664)","Trial Design":"Randomized (2:1), multicenter, open-label trial","Drug Compared":"Pluvicto plus Best Standard of Care (BSoC) vs. BSoC alone","Patient Population":"Men with PSMA-positive mCRPC","Inclusion Criteria":["Received at least one AR pathway inhibitor","Received 1 or 2 prior taxane-based chemotherapy regimens"],"Treatment Regimen":"Pluvicto 7.4 GBq every 6 weeks for up to 6 doses plus BSoC or BSoC alone","Endpoints":["Overall Survival (OS)","Radiographic Progression-Free Survival (rPFS)"],"Statistical Significance":{"OS HR":"0.62","OS HR 95% CI":[0.52,0.74],"OS p-value":"<0.001","Median OS Pluvicto plus BSoC":"15.3 months","Median OS BSoC":"11.3 months"},"Censoring Limitation":"Interpretation of rPFS effect limited due to high degree of censoring from early drop out in control arm"}["Fatigue","Dry mouth","Nausea","Anemia","Decreased appetite","Constipation"]["Radiation exposure","Myelosuppression","Renal toxicity"]"Pluvicto 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses, or until disease progression or unacceptable toxicity"2022-03-23https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer
"pembrolizumab (Keytruda, Merck)""46%""Not reached (68% with response durations \u226512 months and 44% with response durations \u226524 months)""NA""NA""NA""NA""KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label, multi-cohort trial in 90 patients with unresectable or metastatic MSI-H or dMMR endometrial carcinoma in Cohorts D and K"["fatigue","musculoskeletal pain","rash","diarrhea","pyrexia","cough","decreased appetite","pruritis","dyspnea","constipation","pain","abdominal pain","nausea","hypothyroidism"]"Immune-mediated side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions""200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months"2022-03-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-advanced-endometrial-carcinoma
["nivolumab","relatlimab-rmbw (Opdualag)"]"NA""NA"{"Opdualag":{"HR":0.75,"CI":[0.62,0.92],"p-value":0.0055,"Median PFS":{"Opdualag arm":{"months":10.1,"CI":[6.4,15.7]},"Nivolumab arm":{"months":4.6,"CI":[3.4,5.6]}}}}{"HR":0.8,"CI":[0.64,1.01],"Median OS":{"Opdualag arm":{"months":"NR","CI":["34.2","NR"]},"Nivolumab arm":{"months":"34.1","CI":["25.2","NR"]}}}"NA""NA"{"Trial Name":"RELATIVITY-047 (NCT03470922)","Patient Count":714,"Inclusion Criteria":"metastatic or unresectable Stage III or IV melanoma","Exclusion Criteria":["active autoimmune disease","medical conditions requiring systemic treatment with moderate or high dose corticosteroids or immunosuppressive medications","uvea melanoma","active or untreated brain or leptomeningeal metastases"],"Treatment Arms":["Opdualag (nivolumab 480 mg and relatlimab 160 mg)","Nivolumab 480 mg"]}["musculoskeletal pain","fatigue","rash","pruritus","diarrhea"]"NA""480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs"2022-03-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma
"olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP)""NA""NA""NA""NA""NA""NA"{"Study Name":"OlympiA","Study Identifier":"NCT02032823","Study Design":"Randomized (1:1), double-blind, placebo-controlled, international study","Number of Patients":1836,"Endpoint":{"Primary":"Invasive Disease-Free Survival (IDFS)","IDFS Results":{"Olaparib Arm":{"Events":106,"IDFS at 3 years":"86%"},"Placebo Arm":{"Events":178,"IDFS at 3 years":"77%"},"Hazard Ratio":"0.58 (95% CI: 0.46, 0.74)"}}}["nausea","fatigue (including asthenia)","anemia","vomiting","headache","diarrhea","leukopenia","neutropenia","decreased appetite","dysgeusia","dizziness","stomatitis"]"NA""300 mg taken orally twice daily, with or without food for up to one year"2022-03-11https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-adjuvant-treatment-high-risk-early-breast-cancer
"nivolumab (Opdivo, Bristol-Myers Squibb Company)""NA""NA""NA""NA""NA""NA"{"Study":"CHECKMATE-816 (NCT02998528)","Trial design":"Randomized, open label","Population":"Patients with resectable, histologically confirmed Stage IB (\u22654 cm), II, or IIIA NSCLC","Endpoint":{"EFS":{"Median":"31.6 months","CI":"95% CI: 30.2, not reached","Hazard ratio":"0.63 (97.38% CI: 0.43, 0.91; p=0.0052)"},"pCR":{"Rate":"24% (95% CI: 18.0, 31.0) in nivolumab plus chemotherapy arm, 2.2% (95% CI: 0.6, 5.6) in chemotherapy alone arm"}}}["nausea","constipation","fatigue","decreased appetite","rash"]"NA""360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles"2022-03-04https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-nivolumab-and-platinum-doublet-chemotherapy-early-stage-non-small-cell-lung
"null""null""null""null""null""null""null""null""null""null""null"2022-02-28https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma
"null""null""null""null""null""null""null""null""null""null""null"2022-01-25https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma
"abatacept (Orencia, Bristol-Myers Squibb Company)""NA""NA""NA""NA""NA""NA"{"Study 1":{"Study Name":"GVHD-1","Trial Type":"Randomized (1:1), double-blind, placebo-controlled clinical trial","Population":"Patients who underwent an 8 of 8 Human Leukocyte Antigen (HLA)-matched HSCT","Findings":{"Severe aGVHD-free-survival at Day 180":"Not significantly improved with abatacept","OS rate at Day 180":"97% for abatacept group vs. 84% for placebo group","Moderate-severe aGVHD-free survival rate at Day 180":"50% for abatacept group vs. 32% for placebo group"}},"Study 2":{"Study Name":"GVHD-2","Population":"Patients who underwent a 7 of 8 HLA-matched HSCT between 2011 and 2018","Findings":{"OS rate at Day 180":"98% for abatacept group vs. 75% for CNI and MTX alone group"}}}["anemia","hypertension","CMV reactivation\/CMV infection","pyrexia","pneumonia","epistaxis","CD4 lymphocytes decreased","hypermagnesemia","acute kidney injury"]"Patients should receive antiviral prophylaxis for Epstein-Barr virus infection before starting treatment and be monitored for cytomegalovirus infection\/reactivation for six months post-transplantation.""Depends upon the age of the patient and is described in prescribing information."2021-12-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-abatacept-prophylaxis-acute-graft-versus-host-disease
"pembrolizumab (Keytruda, Merck)""NA""NA""NA""NA""NA""NA"{"Trial Name":"KEYNOTE-716","Trial Identifier":"NCT03553836","Trial Design":"multicenter, randomized (1:1), double-blind, placebo-controlled trial","Patient Population":"Adult and pediatric (\u226512 years) patients with completely resected stage IIB or IIC melanoma","Treatment Arms":[{"Arm":"Pembrolizumab","Dose":"200 mg or pediatric (\u226512 years) dose of 2 mg\/kg intravenously (up to a max of 200 mg) every three weeks"},{"Arm":"Placebo","Dose":"NA"}],"Duration":"up to one year or until disease recurrence or unacceptable toxicity","Efficacy Outcome Measure":"recurrence-free survival (RFS)","Results":{"Hazard Ratio":"0.65","95% CI":"0.46, 0.92","p-value":"0.0132","Median RFS":"Not reached"}}["fatigue","diarrhea","pruritus","arthralgia"]"NA"{"Recommended Dosage":"200 mg","Administration":"intravenously every three weeks"}2021-12-03https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-stage-iib-or-iic-melanoma
"rituximab (Rituxan, Genentech, Inc.)""NA""NA""NA""NA""NA""NA"{"Trial name":"Inter-B-NHL Ritux 2010 (NCT01516580)","Patient criteria":"patients \u2265 6 months in age with previously untreated, advanced stage, CD20-positive DLBCL\/BL\/BLL\/B-AL","Intervention":"LMB chemotherapy alone or in combination with rituximab or non-U.S. licensed rituximab","Rituximab dose":"375 mg\/m2 (6 infusions)"}["febrile neutropenia","stomatitis"]"Fatal adverse reactions occurred in <2% of patients""375 mg\/m2 as an intravenous infusion given in combination with systemic LMB chemotherapy"2021-12-02https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-plus-chemotherapy-pediatric-cancer-indications
["Darzalex Faspro","Kyprolis","Dexamethasone"]"84.8%""Not reached""NA""NA""NA""NA""Single-arm cohort of PLEIADES (NCT03412565) with 66 patients"["Upper respiratory tract infections","Fatigue","Insomnia","Hypertension","Diarrhea","Cough","Dyspnea","Headache","Pyrexia","Nausea","Edema peripheral"]"NA"{"Darzalex Faspro":{"Weekly regimen":"1,800 mg\/30,000 units administered subcutaneously once weekly from Weeks 1 to 8, once every 2 weeks from Weeks 9 to 24, and once every 4 weeks starting Week 25"},"Kyprolis":{"Once weekly 20\/70 mg\/m2 regimen":"Kyprolis 20 mg\/m2 on Cycle 1 Day 1, and if tolerated, 70 mg\/m2 on Cycle 1 Day 8 and Day 15, then on Day 1, 8, and 15 of each 28-day cycle","Twice weekly 20\/56 mg\/m2 regimen":"Kyprolis 20 mg\/m2 on Cycle 1 Day 1 and Day 2, and if tolerated, 56 mg\/m2 on Cycle 1 Day 8, 9, 15, and 16, then on Day 1, 2, 8, 9, 15, and 16 of each 28-day cycle"}}2021-12-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-darzalex-faspro-kyprolis-and-dexamethasone-multiple-myeloma
"pafolacianine (Cytalux)""NA""NA""NA""NA""NA""NA"{"Study ID":"NCT03180307","Number of patients":178,"Patient population":"women diagnosed with ovarian cancer or high clinical suspicion","Interventions":["pafolacianine","standard of care evaluation"],"Detection rate with pafolacianine":"26.9%","False positive rate with pafolacianine":"20.2% (95% CI 13.7%, 28.0%)"}["nausea","vomiting","abdominal pain","flushing","dyspepsia","chest discomfort","pruritus","hypersensitivity"]"NA""0.025 mg\/kg administered intravenously over 60 minutes, 1 to 9 hours before surgery"2021-11-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pafolacianine-identifying-malignant-ovarian-cancer-lesions
"sirolimus protein-bound particles""39%""not estimable""NA""NA""2 patients""NA""AMPECT (NCT02494570), a multicenter, single-arm clinical trial in 31 patients with locally advanced unresectable or metastatic malignant PEComa"["stomatitis","fatigue","rash","infection","nausea","edema","diarrhea","musculoskeletal pain","decreased weight","decreased appetite","cough","vomiting","dysgeusia"]"grade 3 to 4 laboratory abnormalities""100 mg\/m2 administered as an IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity"2021-11-23https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-sirolimus-protein-bound-particles-malignant-perivascular-epithelioid-cell-tumor
"pembrolizumab (Keytruda, Merck)""NA""NA""NA""NA""NA""NA"{"Trial Name":"KEYNOTE-564 (NCT03142334)","Trial Design":"multicenter, randomized (1:1), double-blind, placebo-controlled","Total Patients":"994","Treatment Arm":"pembrolizumab 200 mg intravenously every 3 weeks or placebo","Outcome Measures":[{"Measure":"Disease-Free Survival (DFS)","Results":{"HR":"0.68","95% CI":"0.53, 0.87","p-value":"0.0010"}},{"Measure":"Overall Survival (OS)","Results":{"Data":"Not mature at DFS analysis","Deaths":"5% in overall population"}}]}["musculoskeletal pain","fatigue","rash","diarrhea","pruritus","hypothyroidism"]"NA""200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months"2021-11-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma
["asciminib (Scemblix, Novartis AG)"]"25%""Median duration of MMR has not yet been reached""NA""NA""NA""NA"{"ASCEMBL (NCT03106779)":{"Study design":"Multi-center, randomized, active-controlled, open-label clinical trial","Population":"Patients with Ph+ CML in CP, previously treated with two or more TKIs","Treatment arms":"Asciminib 40 mg twice daily vs. bosutinib 500 mg once daily","Outcome measure":"MMR at 24 weeks","Results":"MMR rate was 25% in asciminib group vs. 13% in bosutinib group at 24 weeks"},"CABL001X2101 (NCT02081378)":{"Study design":"Multi-center, open-label clinical trial","Population":"Patients with Ph+ CML in CP with the T315I mutation","Treatment":"Asciminib 200 mg twice daily","Outcome measure":"MMR at 24 and 96 weeks","Results":"MMR was achieved by 42% at 24 weeks and 49% at 96 weeks"}}["Upper respiratory tract infections","Musculoskeletal pain","Fatigue","Nausea","Rash","Diarrhea"]"Decreased platelet counts, increased triglycerides, decreased neutrophil counts, decreased hemoglobin, increased creatine kinase, alanine aminotransferase, lipase, and amylase"{"Ph+ CML in CP":[{"Previouly treated with 2 or more TKIs":["80 mg once daily at approximately the same time each day","40 mg twice daily at approximately 12-hour intervals"]}],"Ph+ CML in CP with T315I mutation":[{"Dose":"200 mg twice daily at approximately 12-hour intervals"}]}2021-10-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-asciminib-philadelphia-chromosome-positive-chronic-myeloid-leukemia
"atezolizumab (Tecentriq, Genentech, Inc.)""NA""NA""NA""NA""NA""NA""Efficacy was demonstrated in a multi-center, randomized, open-label trial (IMpower010, NCT02486718) in patients with stage IB (tumors \u2265 4 cm) through stage IIIA NSCLC (per UICC\/AJCC staging system, 7th edition)."["increased aspartate aminotransferase","blood creatinine","alanine aminotransferase","hyperkalemia","rash","cough","hypothyroidism","pyrexia","fatigue\/asthenia","musculoskeletal pain","peripheral neuropathy","arthralgia","pruritus"]"NA""The recommended atezolizumab dose for this indication is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year."2021-10-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-non-small-cell-lung-cancer
"null""null""null""null""null""null""null""null""null""null""null"2021-10-13https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancer
"abemaciclib (Verzenio,Eli Lilly and Company)""NA""NA""NA""NA""NA""NA"{"Trial":"monarchE (NCT03155997)","Patient Criteria":"HR-positive, HER2-negative, node-positive, resected, early breast cancer with high risk of recurrence and Ki-67 Score \u226520%","Comparison":"abemaciclib plus physician's choice of standard endocrine therapy vs standard endocrine therapy alone","Efficacy Outcome":"Statistically significant improvement in IDFS - HR 0.626, p=0.0042","IDFS at 36 months":{"abemaciclib":"86.1% (95% CI: 82.8, 88.8)","standard therapy":"79.0% (95% CI: 75.3, 82.3)"},"Survival Data":"Not mature at IDFS analysis"}["Diarrhea","Infections","Neutropenia","Fatigue","Leukopenia","Nausea","Anemia","Headache"]"NA""150 mg twice daily in combination with tamoxifen or an aromatase inhibitor for 2 years or until disease recurrence or unacceptable toxicity"2021-10-12https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer
"OncoKB database""NA""NA""NA""NA""NA""NA""NA"["NA","NA"]"NA""NA"2021-10-07https://fda.gov/drugs/resources-information-approved-drugs/fda-recognizes-memorial-sloan-kettering-database-molecular-tumor-marker-information
"brexucabtagene autoleucel (Tecartus)""NA""NA""NA""NA""52%""NA""Evaluated in ZUMA-3 (NCT02614066), a single-arm multicenter trial in adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of brexucabtagene autoleucel following completion of lymphodepleting chemotherapy."["fever","CRS"]"Boxed warning for cytokine release syndrome (CRS) and neurologic toxicities""Single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight (maximum 1 x 108 CAR-positive viable T cells), preceded by fludarabine and cyclophosphamide for lymphodepleting chemotherapy."2021-10-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic
"ruxolitinib (Jakafi, Incyte Corp.)""70%"{"ruxolitinib arm":"4.2 months","BAT arm":"2.1 months"}"NA"{"ruxolitinib arm":"25 months","BAT arm":"5.6 months"}"NA""NA""REACH-3 (NCT03112603), a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best available therapy (BAT) for corticosteroid-refractory cGVHD after allogeneic stem cell transplantation."["anemia","thrombocytopenia"]"NA""10 mg given orally twice daily"2021-09-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ruxolitinib-chronic-graft-versus-host-disease
"Tivdak""24%""8.3 months""NA""NA""NA""NA"{"Trial Name":"innovaTV 204","Trial Type":"Open-label, multicenter, single-arm clinical trial","Clinical Trial Identifier":"NCT03438396","Number of Patients":101,"Patient Criteria":"Recurrent or metastatic cervical cancer with no more than two prior systemic regimens, including one prior platinum-based chemotherapy regimen","Treatment":"Tisotumab vedotin-tftv 2 mg\/kg every 3 weeks","Outcome Measures":{"ORR":"24%","DOR":"8.3 months"}}["Hemoglobin decreased","Fatigue","Lymphocytes decreased","Nausea","Peripheral neuropathy","Alopecia","Epistaxis","Conjunctival adverse reactions","Hemorrhage","Leukocytes decreased","Creatinine increased","Dry eye","Prothrombin international normalized ratio increased","Activated partial thromboplastin time prolonged","Diarrhea","Rash"]"Ocular toxicity (boxed warning)""2 mg\/kg (up to a maximum of 200 mg for patients \u2265100 kg) given as an intravenous infusion over 30 minutes every 3 weeks"2021-09-20https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
"cabozantinib (Cabometyx, Exelixis, Inc.)""18%""NA""11.0 months (95% CI: 7.4, 13.8) in the cabozantinib arm compared to 1.9 months (95% CI 1.9, 3.7) for those receiving placebo""NA""NA""NA""COSMIC-311, a randomized (2:1), double-blind, placebo-controlled, multicenter clinical trial (NCT03690388)"["diarrhea","palmar-plantar erythrodysesthesia (PPE)","fatigue","hypertension","stomatitis"]"Hypocalcemia""Recommended single-agent cabozantinib dose is 60 mg once daily until disease progression or unacceptable toxicity"2021-09-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-differentiated-thyroid-cancer
"mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.)""28%""17.5 months""NA""NA""NA""NA""Study 101, an international, non-randomized, open-label, multicohort clinical trial (NCT02716116) including patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations"["diarrhea","rash","nausea","stomatitis","vomiting","decreased appetite","paronychia","fatigue","dry skin","musculoskeletal pain"]"QTc prolongation and Torsades de Pointes, interstitial lung disease\/pneumonitis, cardiac toxicity, diarrhea""160 mg orally once daily until disease progression or unacceptable toxicity"2021-09-15https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mobocertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
"zanubrutinib (Brukinsa, BeiGene)""56-80%""Not estimable; estimated 1-year rate of DoR was 85%""NA""NA""20%""NA""Based on two open-label, multicenter, single-arm trials: BGB-3111-214 (NCT03846427) and BGB-3111-AU-003 (NCT02343120)"["decreased neutrophil count","upper respiratory tract infection","decreased platelet count","hemorrhage","decreased lymphocyte count","rash","musculoskeletal pain"]"Hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrythmias""160 mg orally twice daily or 320 mg orally once daily"2021-09-14https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-marginal-zone-lymphoma
"zanubrutinib (Brukinsa, BeiGene)""77.5% (95% CI: 68.1,85.1)""94.4% (95% CI: 85.8, 97.9) at 12 months""NA""NA""NA""NA""Investigated in ASPEN (NCT03053440) comparing zanubrutinib and ibrutinib in patients with MYD88 L265P mutation WM. Response rate defined as partial response (PR) or better as assessed by an independent review committee. Duration of response (DOR) measured."["Neutrophil count decreased","Upper respiratory tract infection","Platelet count decreased","Rash","Hemorrhage","Musculoskeletal pain","Hemoglobin decreased","Bruising","Diarrhea","Pneumonia","Cough"]"NA""160 mg orally twice daily or 320 mg orally once daily"2021-09-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-waldenstroms-macroglobulinemia
"ivosidenib (Tibsovo, Servier Pharmaceuticals LLC)""NA""NA""Improvement in PFS for patients randomized to ivosidenib (HR 0.37; 95% CI: 0.25, 0.54; p<0.0001)""Not significant (0.79; 95% CI: 0.56, 1.12; p=0.093)""NA""NA""Ivosidenib investigated in a randomized, multicenter, double-blind, placebo-controlled clinical trial (Study AG120-C-005)"["fatigue","nausea","abdominal pain","diarrhea","cough","decreased appetite","ascites","vomiting","anemia","rash"]"NA""500 mg orally once daily with or without food until disease progression or unacceptable toxicity"2021-08-25https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-advanced-or-metastatic-cholangiocarcinoma
"nivolumab (Opdivo, Bristol-Myers Squibb Co.)""NA""NA""NA""NA""NA""NA"{"Trial name":"CHECKMATE-274 (NCT02632409)","Trial design":"Randomized, double-blind, placebo-controlled","Population":"Patients within 120 days of radical resection of urothelial carcinoma (UC) at high risk of recurrence","Intervention":"Nivolumab 240 mg or placebo by intravenous infusion every 2 weeks for up to 1 year","Endpoints":{"Primary":{"Investigator-assessed disease-free survival (DFS)":{"ITT population":"HR 0.70; 95% CI: 0.57, 0.86; p=0.0008","PD-L1 \u22651%":"HR 0.55; 95% CI: 0.39, 0.77; p=0.0005"}},"Exploratory":{"PD-L1-negative tumors":"HR 0.83; 95% CI: 0.64, 1.08"}}}["rash","fatigue","diarrhea","pruritus","musculoskeletal pain","urinary tract infection"]"NA""240 mg every 2 weeks or 480 mg every 4 weeks"2021-08-19https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma
"dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC)""41.6%""34.7 months""NA""NA""9.1%""32.5%""GARNET Trial (NCT02715284)"["Fatigue\/Asthenia","Anemia","Diarrhea","Nausea"]"Immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic toxicity""500 mg every 3 weeks for dose 1 through 4, subsequent dosing 1,000 mg every 6 weeks"2021-08-18https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-advanced-solid-tumors
["belzutifan"]{"VHL-associated RCC":"49%","CNS hemangioblastomas":"63%","pNET":"83%"}{"VHL-associated RCC":"56% responders with DOR \u2265 12 months","CNS hemangioblastomas":"73% responders with DOR \u2265 12 months","pNET":"50% responders with DOR \u2265 12 months"}"not mentioned""not mentioned""not mentioned""not mentioned"{"Study":"Study 004 (NCT03401788)","Patient Population":"adult patients with VHL-associated RCC","Endpoints":["ORR by RECIST v1.1","DOR","TTR"]}["decreased hemoglobin","anemia","fatigue","increased creatinine","headache","dizziness","increased glucose","nausea"]["severe anemia and hypoxia","belzutifan use rendering some hormonal contraceptives ineffective","embryo-fetal harm with belzutifan exposure during pregnancy"]"120 mg orally once daily with or without food"2021-08-13https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-cancers-associated-von-hippel-lindau-disease
["Lenvima","Keytruda"]{"combination":"71%","sunitinib":"36%"}"NA"{"combination":"23.9 months","sunitinib":"9.2 months"}"NA"{"combination":"16%","sunitinib":"4%"}"NA""CLEAR (Study 307\/KEYNOTE-581; NCT02811861)"["fatigue","diarrhea","musculoskeletal pain","hypothyroidism","hypertension","stomatitis","decreased appetite","rash","nausea","decreased weight","dysphonia","proteinuria","palmar-plantar erythrodysesthesia syndrome","abdominal pain","hemorrhagic events","vomiting","constipation","hepatotoxicity","headache","acute kidney injury"]["arterial thrombotic events (5%) including myocardial infarction (3.4%) and cerebrovascular accident (2.3%)"]{"lenvatinib":"20 mg orally once daily","pembrolizumab":"200 mg administered as an intravenous infusion over 30 minutes every 3 weeks or 400 mg administered as an intravenous infusion over 30 minutes every 6 weeks up to 2 years"}2021-08-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-plus-pembrolizumab-advanced-renal-cell-carcinoma
"pembrolizumab (Keytruda, Merck)""NA""NA""NA""NA""NA""NA""The efficacy of pembrolizumab in combination with neoadjuvant chemotherapy followed by surgery and continued adjuvant treatment with pembrolizumab as a single agent was investigated in KEYNOTE-522 (NCT03036488), a randomized, multicenter, double-blind, placebo-controlled trial conducted in 1174 patients with newly diagnosed previously untreated high-risk early-stage TNBC (tumor size >1 cm but \u22642 cm in diameter with nodal involvement or tumor size >2 cm in diameter regardless of nodal involvement)."["fatigue\/asthenia","nausea","constipation","diarrhea","decreased appetite","rash","vomiting","cough","dyspnea","pyrexia","alopecia","peripheral neuropathy","mucosal inflammation","stomatitis","headache","weight loss","abdominal pain","arthralgia","myalgia","insomnia"]"NA""The recommended dosage of pembrolizumab for TNBC is 200 mg every 3 weeks or 400 mg every 6 weeks as an intravenous infusion over 30 minutes. Pembrolizumab is administered in combination with chemotherapy for neoadjuvant treatment for 24 weeks, and then as a single agent for adjuvant treatment for up to 27 weeks."2021-07-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-high-risk-early-stage-triple-negative-breast-cancer
["pembrolizumab","lenvatinib"]{"pembrolizumab_lenvatinib":"30%","chemotherapy":"15%"}{"pembrolizumab_lenvatinib":"9.2 months","chemotherapy":"5.7 months"}{"pembrolizumab_lenvatinib":"6.6 months","chemotherapy":"3.8 months"}{"pembrolizumab_lenvatinib":"17.4 months","chemotherapy":"12.0 months"}"NA""NA"{"study_name":"Study 309\/KEYNOTE-775","enrolled_patients":827,"treatment_comparison":"pembrolizumab + lenvatinib vs. investigator's choice of chemotherapy","major_outcome_measures":["PFS","OS","ORR","DOR"],"results_summary":"Significantly improved PFS, OS, ORR with pembrolizumab + lenvatinib compared to chemotherapy."}["hypothyroidism","hypertension"]"NA"{"pembrolizumab":["200 mg every 3 weeks","400 mg every 6 weeks"],"lenvatinib":"20 mg orally once daily"}2021-07-21https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-pembrolizumab-and-lenvatinib-advanced-endometrial-carcinoma
"belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC)""75%""1.9 months""NA""NA""6%""69%""KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging trial with 65 patients"["infections","asthenia","nausea","diarrhea","dyspnea","cough","edema","hemorrhage","abdominal pain","musculoskeletal pain","headache","phosphate decreased","gamma glutamyl transferase increased","lymphocytes decreased","hypertension"]"NA""200 mg taken orally once daily with food"2021-07-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-belumosudil-chronic-graft-versus-host-disease
"daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.)""NA""NA""12.4 months""NA""NA""NA""APOLLO (NCT03180736) with 304 patients randomized (1:1) to Darzalex Faspro with pomalidomide and dexamethasone (Pd) vs Pd alone"["fatigue","pneumonia","upper respiratory tract infection","diarrhea"]"NA""1,800 mg\/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to the recommended schedule"2021-07-09https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma
"enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.)""40.6%""13.8 months""5.6 months""12.9 months""22%""18.6%""Trial EV-301 (NCT03474107) - open-label, randomized, multicenter trial with 608 patients"["rash","peripheral neuropathy"]"Serious skin reactions (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis), pneumonitis""1.25 mg\/kg administered intravenously over 30 minutes on days 1, 8, and 15 of a 28-day cycle"2021-07-09https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-enfortumab-vedotin-ejfv-locally-advanced-or-metastatic-urothelial-cancer
"asparaginase erwinia chrysanthemi (recombinant)-rywn""NA""NA""NA""NA""NA""NA""Study JZP458-201 (NCT04145531), open-label, multi-cohort trial in 102 patients with ALL or LBL with hypersensitivity to E. coli-derived asparaginase"["abnormal liver test","nausea","musculoskeletal pain","fatigue","infection","headache","pyrexia","drug hypersensitivity","febrile neutropenia","decreased appetite","stomatitis","bleeding","hyperglycemia"]"NA""25 mg\/m^2 administered intramuscularly every 48 hours"2021-07-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma
"avapritinib (Ayvakit\u2122, Blueprint Medicines Corp.)""57%""38.3 months""NA""NA""28%""28%""EXPLORER (NCT02561988) and PATHFINDER (NCT03580655) trials"["edema","diarrhea","nausea","fatigue\/asthenia"]"Not recommended for patients with AdvSM with platelet counts less than 50 X 10^9\/L""200 mg orally once daily for patients with AdvSM"2021-06-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-avapritinib-advanced-systemic-mastocytosis
"infigratinib (Truseltiq)""23%""5 months""NA""NA""1""24""CBGJ398X2204 (NCT02150967), a multicenter open-label single-arm trial"["hyperphosphatemia","increased creatinine","nail toxicity","stomatitis","dry eye","fatigue","alopecia","palmar-plantar erythrodysesthesia syndrome","arthralgia","dysgeusia","constipation","abdominal pain","dry mouth","eyelash changes","diarrhea","dry skin","decreased appetite","vision blurred","vomiting"]["hyperphosphatemia","retinal pigment epithelial detachment"]"125 mg orally once daily on an empty stomach for 21 consecutive days followed by 7 days off therapy, in 28-day cycles"2021-05-28https://fda.gov/drugs/resources-information-approved-drugs/withdrawn-fda-grants-accelerated-approval-infigratinib-metastatic-cholangiocarcinoma
"Lumakras (sotorasib)""36%""10 months""NA""NA""NA""NA""CodeBreaK 100, NCT03600883, locally advanced or metastatic NSCLC with KRAS G12C mutations"["diarrhea","musculoskeletal pain","nausea","fatigue","hepatotoxicity","cough"]"NA""960 mg orally daily until disease progression or unacceptable toxicity"2021-05-28https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc
"null""null""null""null""null""null""null""null""null""null""null"2021-05-21https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-amivantamab-vmjw-metastatic-non-small-cell-lung-cancer
"nivolumab (Opdivo, Bristol-Myers Squibb Company)""NA""NA""NA""NA""NA""NA""The efficacy was evaluated in CHECKMATE-577 (NCT02743494), a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal or GEJ cancers who had residual pathologic disease following concurrent chemoradiotherapy. Patients were randomized (2:1) to receive either nivolumab 240 mg or placebo every 2 weeks for 16 weeks followed by 480 mg of nivolumab or placebo every 4 weeks beginning at week 17 for up to one year of treatment."["fatigue","rash","musculoskeletal pain","pruritus","diarrhea","nausea","asthenia","cough","dyspnea","constipation","decreased appetite","back pain","arthralgia","upper respiratory tract infection","pyrexia","headache","abdominal pain","vomiting"]"NA""The recommended nivolumab dose for adjuvant treatment of resected esophageal or GEJ cancer is 240 mg every 2 weeks or 480 mg every 4 weeks for a total treatment duration of 1 year. Both doses are administered as 30-minute intravenous infusions."2021-05-20https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-resected-esophageal-or-gej-cancer
"pembrolizumab (Keytruda, Merck & Co.)""74%""10.6 months""NA""NA""NA""NA""Approval based on prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial"["NA"]"NA""200 mg every 3 weeks or 400 mg every 6 weeks"2021-05-05https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab-her2-positive-gastric-cancer
"loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA)""48.3%""10.3 months""NA""NA""24.1%""NA""LOTIS-2 (NCT03589469), open-label, single-arm trial in 145 adult patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma"["thrombocytopenia","increased gamma-glutamyltransferase","neutropenia","anemia","hyperglycemia","transaminase elevation","fatigue","hypoalbuminemia","rash","edema","nausea","musculoskeletal pain"]"Edema and effusions, myelosuppression, infections, cutaneous reactions""0.15 mg\/kg every 3 weeks for 2 cycles, then 0.075 mg\/kg every 3 weeks for subsequent cycles, by intravenous infusion over 30 minutes"2021-04-23https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma
"dostarlimab-gxly (Jemperli)""42.3%""Median DOR was not reached, with 93.3% of patients having durations \u22656 months (range: 2.6 to 22.4 months, ongoing at last assessment)""NA""NA""12.7%""29.6%""Efficacy was evaluated based on cohort (A1) in GARNET Trial (NCT02715284), a multicenter, multicohort, open-label trial in patients with advanced solid tumors. The efficacy population consisted of 71 patients with dMMR recurrent or advanced endometrial cancer who progressed on or after a platinum-containing regimen. Patients received dostarlimab-gxly, 500 mg intravenously, every 3 weeks for 4 doses followed by 1,000 mg intravenously every 6 weeks."["Fatigue\/asthenia","Nausea","Diarrhea","Anemia","Constipation"]"Immune-mediated adverse reactions can occur including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.""The recommended dostarlimab-gxly dose and schedule (doses 1 through 4) is 500 mg every 3 weeks. Subsequent dosing, beginning 3 weeks after dose 4, is 1,000 mg every 6 weeks until disease progression or unacceptable toxicity. Dostarlimab-gxly should be administered as an intravenous infusion over 30 minutes."2021-04-22https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-endometrial-cancer
"null""null""null""null""null""null""null""null""null""null""null"2021-04-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-combination-chemotherapy-metastatic-gastric-cancer-and-esophageal
"sacituzumab govitecan (Trodelvy, Immunomedics Inc.)""27.7%""7.2 months""NA""NA""5.4%""22.3%""TROPHY (IMMU-132-06; NCT03547973)"["neutropenia","nausea","diarrhea","fatigue","alopecia","anemia","vomiting","constipation","decreased appetite","rash","abdominal pain"]"NA""10 mg\/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity"2021-04-13https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer
"sacituzumab govitecan (Trodelvy, Immunomedics Inc.)""NA""NA"{"Median PFS for patients receiving sacituzumab govitecan":"4.8 months (95% CI: 4.1, 5.8)","Median PFS for patients receiving chemotherapy":"1.7 months (95% CI: 1.5, 2.5)","Hazard Ratio (sacituzumab govitecan vs. chemotherapy)":"0.43 (95% CI: 0.35, 0.54)","p-value":"<0.0001"}{"Median OS for patients receiving sacituzumab govitecan":"11.8 months (95% CI: 10.5, 13.8)","Median OS for patients receiving chemotherapy":"6.9 months (95% CI: 5.9, 7.6)","Hazard Ratio (sacituzumab govitecan vs. chemotherapy)":"0.51 (95% CI: 0.41, 0.62)","p-value":"<0.0001"}"NA""NA"{"Trial name":"ASCENT (NCT02574455)","Trial design":"Multicenter, open-label, randomized trial","Number of patients":529,"Dosage":"sacituzumab govitecan, 10 mg\/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle","Endpoints":{"Primary endpoint":"Progression-free survival (PFS) in patients without brain metastases at baseline","Additional endpoints":["PFS for the full population","Overall survival (OS)"]}}["Nausea","Neutropenia","Diarrhea","Fatigue","Alopecia","Anemia","Vomiting","Constipation","Rash","Decreased appetite","Abdominal pain"]"NA""10 mg\/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity"2021-04-07https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-sacituzumab-govitecan-triple-negative-breast-cancer
"cetuximab (Erbitux, ImClone LLC)""NA""NA""NA""NA""NA""NA"{"populationPKModeling":true,"pooledAnalyses":true,"observedEfficacyResults":true}["cutaneous adverse reactions","headache","diarrhea","infection"]"NA"{"dosageRegimen":"500 mg\/ m2 as a 120-minute intravenous infusion every two weeks (Q2W)","indications":"K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN)"}2021-04-06https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-cetuximab
"isatuximab-irfc (Sarclisa)""NA""NA""Not reached in the Isa-Kd arm; 20.27 months (95% CI: 15.77-NR) in the Kd arm (HR 0.548; 95% CI: 0.366-0.822; p=0.0032)""NA""NA""NA""Evaluated in IKEMA (NCT03275285), a phase 3 trial with 302 patients comparing Isa-Kd vs Kd"["Upper respiratory tract infection","Infusion-related reactions","Fatigue","Hypertension","Diarrhea","Pneumonia","Dyspnea","Insomnia","Bronchitis","Cough","Back pain"]"NA""10 mg\/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks until disease progression or unacceptable toxicity"2021-03-31https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-multiple-myeloma
"null""null""null""null""null""null""null""null""null""null""null"2021-03-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-multiple-myeloma
"Pembrolizumab (Keytruda)""NA""NA""6.3 months""12.4 months""NA""NA""KEYNOTE-590 (NCT03189719)"["nausea","constipation","diarrhea","vomiting","stomatitis","fatigue\/asthenia","decreased appetite","weight loss"]"NA""200 mg every 3 weeks or 400 mg every 6 weeks"2021-03-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-esophageal-or-gej-carcinoma
"tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.)"{"tivozanib arm":"18% (95% CI: 12%, 24%)","sorafenib arm":"8% (95% CI: 4%, 13%)"}"NA"{"tivozanib arm":"5.6 months (95% CI: 4.8, 7.3)","sorafenib arm":"3.9 months (95% CI: 3.7, 5.6)"}{"tivozanib arm":"16.4 months (95% CI: 13.4, 21.9)","sorafenib arm":"19.2 months (95% CI: 14.9, 24.2)"}"NA""NA""TIVO-3 (NCT02627963), a randomized (1:1), open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced RCC who received two or three prior systemic treatments."["fatigue","hypertension","diarrhea","decreased appetite","nausea","dysphonia","hypothyroidism","cough","stomatitis"]"The most common grade 3 or 4 laboratory abnormalities (\u22655%) were decreased sodium, increased lipase, and decreased phosphate.""1.34 mg once daily for 21 consecutive days every 28 days until disease progression or unacceptable toxicity"2021-03-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma
"null""null""null""null""null""null""null""null""null""null""null"2021-03-05https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-axicabtagene-ciloleucel-relapsed-or-refractory-follicular-lymphoma
"Lorbrena""NA"">12 months""NA""Immature data at PFS analysis""NA""NA""Study B7461006"["Edema","Peripheral neuropathy","Weight gain","Cognitive effects","Fatigue","Dyspnea","Arthralgia","Diarrhea","Mood effects","Hypercholesterolemia","Hypertriglyceridemia","Cough"]"NA""100 mg orally once daily"2021-03-03https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lorlatinib-metastatic-alk-positive-nsclc
"null""null""null""null""null""null""null""null""null""null""null"2021-02-26https://fda.gov/drugs/resources-information-approved-drugs/withdrawn-fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple
"Cemiplimab-rwlc (Libtayo)""37%""NA"{"Cemiplimab-rwlc":"6.2 months","Chemotherapy":"5.6 months"}{"Cemiplimab-rwlc":"22.1 months","Chemotherapy":"14.3 months"}"NA""NA""Study 1624 (NCT03088540)"["Musculoskeletal pain","Rash","Anemia","Fatigue","Decreased appetite","Pneumonia","Cough"]"NA""350 mg every 3 weeks, intravenously over 30 minutes"2021-02-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-non-small-cell-lung-cancer-high-pd-l1-expression
"cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.)"{"laBCC":29,"mBCC":21}{"laBCC":"not reached","mBCC":"not reached"}"NA""NA""NA""NA""Study 1620 (NCT03132636), open-label trial on patients with advanced BCC (laBCC or mBCC) who had progressed on HHI therapy"["fatigue","musculoskeletal pain","diarrhea","rash","pruritis"]"Severe immune-mediated adverse reactions (e.g. pneumonitis, hepatitis, colitis)""350 mg as an intravenous infusion over 30 minutes every 3 weeks"2021-02-09https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-locally-advanced-and-metastatic-basal-cell-carcinoma
"lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.)""73% (95% CI: 67, 80)""Not reached (95% CI: 16.7 months, NR) in patients who achieved a CR. 1.4 months (95% CI: 1.1, 2.2) among patients with partial response""NA""NA""54% (95% CI: 47, 61)""NA""Efficacy was evaluated in TRANSCEND (NCT02631044), a single-arm, open label, multicenter trial that evaluated lisocabtagene maraleucel, preceded by lymphodepleting chemotherapy, in adults with R\/R large B-cell lymphoma after at least two lines of therapy."["Cytokine release syndrome (CRS) occurred in 46% of patients (Grade 3 or higher, 4%)","Neurologic toxicity occurred in 35% (Grade 3 or higher, 12%)"]"FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening CRS and neurologic toxicities.""The recommended regimen is a single dose containing 50 to 110 x 10^6 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components, administered by IV infusion and preceded by fludarabine and cyclophosphamide for lymphodepletion. Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system lymphoma."2021-02-05https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma
"Umbralisib (Ukoniq)"{"Marginal Zone Lymphoma (MZL)":"49%","Follicular Lymphoma (FL)":"43%"}{"Marginal Zone Lymphoma (MZL)":"Not reached","Follicular Lymphoma (FL)":"11.1 months"}"NA""NA"{"Marginal Zone Lymphoma (MZL)":"16%","Follicular Lymphoma (FL)":"3%"}"NA""UTX-TGR-205 (NCT02793583) in 69 patients with MZL and 117 patients with FL"["Increased creatinine","Diarrhea-colitis","Fatigue","Nausea","Neutropenia","Transaminase elevation","Musculoskeletal pain","Anemia","Thrombocytopenia","Upper respiratory tract infection","Vomiting","Abdominal pain","Decreased appetite","Rash"]"Infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, severe cutaneous reactions""800 mg orally once daily with food until disease progression or unacceptable toxicity"2021-02-05https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-umbralisib-marginal-zone-lymphoma-and-follicular-lymphoma
"tepotinib (Tepmetko, EMD Serono Inc.)""43%""10.8 to 11.1 months""NA""NA""NA""NA""VISION trial (NCT02864992) - 152 patients with NSCLC with MET exon 14 skipping alterations received tepotinib 450 mg orally once daily"["Edema","Fatigue","Nausea","Diarrhea","Musculoskeletal pain","Dyspnea"]["Interstitial lung disease","Hepatotoxicity","Embryo-fetal toxicity"]"450 mg orally once daily with food"2021-02-03https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer
["nivolumab (Opdivo)","cabozantinib (Cabometyx)"]{"nivolumab plus cabozantinib":"55.7%","sunitinib":"27.1%"}"NA"{"nivolumab plus cabozantinib":"16.6 months","sunitinib":"8.3 months"}"Not reached in either arm""NA""NA"{"Trial name":"CHECKMATE-9ER","Trial identifier":"NCT03141177","Patient population":"Patients with previously untreated advanced RCC","Treatment arms":{"nivolumab plus cabozantinib":"n=323","sunitinib":"n=328"}}["diarrhea","fatigue","hepatotoxicity","palmar-plantar erythrodysaesthesia syndrome","stomatitis","rash","hypertension","hypothyroidism","musculoskeletal pain","decreased appetite","nausea","dysgeusia","abdominal pain","cough","upper respiratory tract infection"]"NA"{"nivolumab":["240 mg every 2 weeks (30-minute IV infusion)","480 mg every 4 weeks (30-minute IV infusion)"],"cabozantinib":"40 mg orally once daily without food until disease progression or unacceptable toxicity"}2021-01-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-plus-cabozantinib-advanced-renal-cell-carcinoma
"null""null""null""null""null""null""null""null""null""null""null"2021-01-15https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis
"null""null""null""null""null""null""null""null""null""null""null"2021-01-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas
"Xalkori (crizotinib)""88%""39% maintained response for at least 6 months, 22% maintained response for at least 12 months""NA""NA""81%""NA""Study ADVL0912 (NCT00939770) in patients 1 to \u226421 years of age with relapsed or refractory, systemic ALK-positive ALCL"["diarrhea","vomiting","nausea","vision disorder","headache","musculoskeletal pain","stomatitis","fatigue","decreased appetite","pyrexia","abdominal pain","cough","pruritus"]"Ocular toxicity (Grade 1 or 2 visual disorders occurred in 65% of patients), gastrointestinal toxicity occurred in 92%, serious adverse reactions occurred in 35% (most often neutropenia and infection)""280 mg\/m2 orally twice daily based on body surface area"2021-01-14https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-crizotinib-children-and-young-adults-relapsed-or-refractory-systemic-anaplastic-large
"osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP)""NA""NA""Not reached in patients on the osimertinib arm compared with 19.6 months on the placebo arm""NA""NA""NA""Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC"["lymphopenia","leukopenia","thrombocytopenia","diarrhea","anemia","rash","musculoskeletal pain","nail toxicity","neutropenia","dry skin","stomatitis","fatigue","cough"]"NA""80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years"2020-12-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations
"null""null""null""null""null""null""null""null""null""null""null"2020-12-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-relugolix-advanced-prostate-cancer
"selinexor""NA""NA""13.9 months (95% CI: 11.7, Not Estimable) for the SVd arm and 9.5 months (95% CI: 7.6, 10.8) for the Vd arm""NA""NA""NA""BOSTON Trial (KCP-330-023, NCT03110562), a randomized (1:1) open-label, multicenter, active comparator-controlled trial in patients with RRMM"["nausea","fatigue","decreased appetite","diarrhea","peripheral neuropathy","upper respiratory tract infection","decreased weight","cataract","vomiting"]"Thrombocytopenia, neutropenia, gastrointestinal toxicity, hyponatremia, serious infection, neurological toxicity, embryo-fetal toxicity, and cataract""100 mg orally once weekly on day 1 of each week of a 35-day cycle in combination with Bortezomib 1.3 mg\/m^2 administered subcutaneously once weekly and Dexamethasone 20 mg taken orally twice weekly on days 1 and 2 of each week"2020-12-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-refractory-or-relapsed-multiple-myeloma
"margetuximab-cmkb (MARGENZA, MacroGenics)""22% (margetuximab arm) vs 16% (control arm)""6.1 months (margetuximab arm) vs 6.0 months (control arm)""5.8 months (margetuximab arm) vs 4.9 months (control arm)""NA""NA""NA""SOPHIA (NCT02492711), randomized trial of 536 patients with metastatic HER2-positive breast cancer"["fatigue\/asthenia","nausea","diarrhea","vomiting","constipation","headache","pyrexia","alopecia","abdominal pain","peripheral neuropathy","arthralgia\/myalgia","cough","decreased appetite","dyspnea","infusion-related reactions","palmar-plantar erythrodysesthesia","extremity pain"]"Left ventricular dysfunction and embryo-fetal toxicity""15 mg\/kg by intravenous infusion over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks"2020-12-16https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-margetuximab-metastatic-her2-positive-breast-cancer
"pralsetinib (GAVRETO, Blueprint Medicines Corporation)"{"Advanced or metastatic RET-mutant MTC (prior cabozantinib or vandetanib)":"60%","Advanced or metastatic RET-mutant MTC (no prior cabozantinib or vandetanib)":"66%","RET fusion-positive thyroid cancer (radioactive iodine-refractory)":"89%"}{"Advanced or metastatic RET-mutant MTC (prior cabozantinib or vandetanib)":"79% had responses lasting 6 months or longer","Advanced or metastatic RET-mutant MTC (no prior cabozantinib or vandetanib)":"84% had responses lasting 6 months or longer","RET fusion-positive thyroid cancer (radioactive iodine-refractory)":"All responding patients had responses lasting 6 months or longer"}"NA""NA""NA""NA"{"Trial name":"ARROW","Trial identifier":"NCT03037385","Trial design":"Multicenter, open label, multi-cohort clinical trial","RET gene alterations identification":"Next generation sequencing, fluorescence in situ hybridization, or other tests","Blinded independent review committee":"Used RECIST 1.1 for assessment"}["Constipation","Hypertension","Fatigue","Musculoskeletal pain","Diarrhea"]["Decreased lymphocytes","Decreased neutrophils","Decreased hemoglobin","Decreased phosphate","Decreased calcium (corrected)","Decreased sodium","Increased AST","Increased ALT","Decreased platelets","Increased alkaline phosphatase"]"400 mg orally once daily on an empty stomach with no food intake for at least 2 hours before and at least 1 hour after taking pralsetinib"2020-12-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pralsetinib-ret-altered-thyroid-cancers
"Sonalleve MR-HIFU system (Profound Medical Inc.)""NA""NA""NA""NA""NA""NA""Efficacy was evaluated in a study of nine patients treated with MR-HIFU, without technical difficulties or serious adverse events. There was a statistically significant decrease in their pain scores within 4 weeks of treatment. No pain medication usage was achieved in 8 of 9 patients after 4 weeks."["NA","NA"]"The device should not be used under certain conditions. For full information including warnings and precautions, view the Summary of Safety and Probable Benefit Document for the Sonalleve MR-HIFU system at https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfhde\/hde.cfm?id=H190003.""NA"2020-11-27https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-device-treatment-osteoid-osteoma-extremities
"naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.)""45% (Study 201), 34% (Study 12-230)""30% responders \u22656 months (Study 201), 23% patients \u22656 months (Study 12-230)""NA""NA""NA""NA""Efficacy evaluated in patients with relapsed or refractory neuroblastoma in the bone or bone marrow in Study 201 (NCT 03363373) and Study 12-230 (NCT 01757626)"["infusion-related reactions","pain","tachycardia","vomiting","cough","nausea","diarrhea","decreased appetite","hypertension","fatigue","erythema multiforme","peripheral neuropathy","urticaria","pyrexia","headache","injection site reaction","edema","anxiety","localized edema","irritability"]"Serious infusion-related reactions and neurotoxicity including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS)""3 mg\/kg\/day (up to 150 mg\/day) on days 1, 3, and 5 of each treatment cycle, administered after dilution as an intravenous infusion in combination with GM-CSF, subcutaneously at 250 \u00b5g\/m^2\/day on days -4 to 0 and at 500 \u00b5g\/m^2\/day on days 1 to 5. Treatment cycles are repeated every 4 to 8 weeks"2020-11-25https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-naxitamab-high-risk-neuroblastoma-bone-or-bone-marrow
"pembrolizumab (KEYTRUDA, Merck & Co.)""NA""NA""9.7 months (95% CI: 7.6, 11.3) in the pembrolizumab plus chemotherapy arm and 5.6 months (95% CI:5.3, 7.5) in the placebo arm""NA""NA""NA""Approval was based on KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial in patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting."["fatigue","nausea","diarrhea","constipation","vomiting","alopecia","rash","cough","decreased appetite","headache"]"NA""The recommended pembrolizumab dose for adult patients with locally recurrent unresectable or metastatic TNBC is 200 mg every 3 weeks or 400 mg every 6 weeks administered prior to chemotherapy until disease progression, unacceptable toxicity, or up to 24 months."2020-11-13https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple
"FoundationOne Liquid CDx test""null""null""null""null""null""null""null""null""null""null"2020-10-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-liquid-biopsy-ngs-companion-diagnostic-test-multiple-cancers-and-biomarkers
"larotrectinib""NA""NA""NA""NA""NA""NA""Approval of larotrectinib was based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). Identification of positive NTRK gene fusion status was prospectively determined in local laboratories using NGS, fluorescence in situ hybridization (FISH), and reverse transcriptase- polymerase chain reaction (RT-PCR) methods."["NA","NA"]"NA""NA"2020-10-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-companion-diagnostic-identify-ntrk-fusions-solid-tumors-vitrakvi
"venetoclax (VENCLEXTA \u00ae, AbbVie Inc. and Genentech Inc.)""NA""NA""NA"{"VIALE-A (venetoclax plus azacitidine)":{"Median":"14.7 months","95% CI":"[11.9, 18.7]","HR":"0.66","p-value":"<0.001"},"VIALE-C (venetoclax plus LDAC)":{"HR":"0.75","95% CI":"[0.52, 1.07]","p-value":"0.114"}}{"VIALE-A (venetoclax plus azacitidine)":"37%","VIALE-C (venetoclax plus LDAC)":"27%"}"NA"{"VIALE-A (venetoclax plus azacitidine)":{"n":{"venetoclax plus azacitidine":286,"placebo plus azacitidine":145}},"VIALE-C (venetoclax plus LDAC)":{"n":{"venetoclax plus LDAC":143,"placebo plus LDAC":68}}}["nausea","diarrhea","thrombocytopenia","constipation","neutropenia","febrile neutropenia","fatigue","vomiting","edema","pyrexia","pneumonia","dyspnea","hemorrhage","anemia","rash","abdominal pain","sepsis","musculoskeletal pain","dizziness","cough","oropharyngeal pain","hypotension"]"NA""Depends upon the combination regimen as described in prescribing information"2020-10-16https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-venetoclax-combination-untreated-acute-myeloid-leukemia
"null""null""null""null""null""null""null""null""null""null""null"2020-10-14https://fda.gov/drugs/resources-information-approved-drugs/fda-extends-approval-pembrolizumab-classical-hodgkin-lymphoma
"null""null""null""null""null""null""null""null""null""null""null"2020-10-02https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-ipilimumab-unresectable-malignant-pleural-mesothelioma
"Atezolizumab (Tecentriq) and paclitaxel""NA""NA""NA""NA""NA""NA""IMpassion131 trial, phase 3, multicenter, randomized, double-blind, placebo-controlled trial of atezolizumab in combination with paclitaxel compared with placebo and paclitaxel for patients with mTNBC."["NA"]"Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.""Atezolizumab in combination with paclitaxel not recommended for use in breast cancer. Atezolizumab in combination with paclitaxel protein-bound (Abraxane) currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1."2020-09-08https://fda.gov/drugs/resources-information-approved-drugs/fda-issues-alert-about-efficacy-and-potential-safety-concerns-atezolizumab-combination-paclitaxel
["pralsetinib"]"57%""6+ months""Data not provided""Data not provided""NA""NA""Multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385) in patients whose tumors had RET alterations. Identification of RET gene alterations was prospectively determined in local laboratories using either next generation sequencing, fluorescence in situ hybridization, or other tests. The main efficacy outcome measures were overall response rate (ORR) and response duration determined by a blinded independent review committee using RECIST 1.1."["increased aspartate aminotransferase (AST)","decreased hemoglobin","decreased lymphocytes","decreased neutrophils","increased alanine aminotransferase (ALT)","increased creatinine","increased alkaline phosphatase","fatigue","constipation","musculoskeletal pain","decreased calcium","hypertension","decreased sodium","decreased phosphate","decreased platelets"]"Data not provided""400 mg orally once daily on an empty stomach"2020-09-04https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pralsetinib-lung-cancer-ret-gene-fusions
["azacitidine tablets (ONUREG)"]"NA""NA""NA"{"Onureg arm":{"Median":"24.7 months","95% CI":[18.7,30.5],"HR":0.69,"p-value":0.0009},"Placebo arm":{"Median":"14.8 months","95% CI":[11.7,17.6]}}"NA""NA"{"Trial":"QUAZAR (NCT01757535)","Design":"Multicenter, randomized, double-blind, placebo-controlled trial","Patients":{"Total":472,"Treatment groups":{"Onureg arm":{"Count":238},"Placebo arm":{"Count":234}}},"Intervention":{"Onureg dose":"300 mg orally once daily with or without food on days 1 through 14 of each 28-day cycle","Duration":"Until disease progression or unacceptable toxicity"}}["Nausea","Vomiting","Diarrhea","Fatigue\/Asthenia","Constipation","Pneumonia","Abdominal pain","Arthralgia","Decreased appetite","Febrile neutropenia","Dizziness","Pain in extremity"]"NA""300 mg orally once daily with or without food on days 1 through 14 of each 28-day cycle"2020-09-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-onureg-azacitidine-tablets-acute-myeloid-leukemia
"Guardant360 CDx""NA""NA""NA""NA""NA""NA""NA"["NA"]"NA""NA"2020-08-26https://fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test
["carfilzomib (KYPROLIS)","daratumumab (DARZALEX)"]"81%""27.5 months""HR 0.63; 95% CI: 0.46, 0.85; 1-sided p-value 0.0014""NA""NA""NA"{"CANDOR":{"Study":"NCT03158688","Trial type":"Randomized, open label, multicenter trial","Number of patients":466,"Arms":{"DKd arm":312,"Kd arm":154}},"EQUULEUS":{"Study":"NCT01998971","Trial type":"Open label, multicohort trial","Number of patients":85}}["infusion related reactions","anemia","diarrhea","fatigue","hypertension","pyrexia","respiratory tract infection","thrombocytopenia","neutropenia","lymphopenia","cough","dyspnea","insomnia","headache","back pain"]"NA"{"carfilzomib":{"Once weekly 20\/70 mg\/m\u00b2 regimen":"administer carfilzomib intravenously as a 30-minute infusion on Days 1, 8, and 15 of each 28-day cycle at a dose of 20 mg\/m\u00b2 on Cycle 1 Day 1 and, if tolerated, increased to 70 mg\/m\u00b2 on Cycle 1 Day 8 and thereafter","Twice weekly 20\/56 mg\/m\u00b2 regimen":"administer carfilzomib intravenously as a 30-minute infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle at a dose of 20 mg\/m\u00b2 on Days 1 and 2 of Cycle 1 and, if tolerated, increased to 56 mg\/m\u00b2 on Cycle 1 Day 8 and thereafter"},"daratumumab":"16 mg\/kg actual body weight administered as split dosing of 8 mg\/kg on Days 1 and 2 of Cycle 1, followed by standard dosing of 16 mg\/kg for subsequent doses administered weekly from Weeks 2 to 8, every two weeks from Weeks 9 to 24, and every four weeks from Week 25 and thereafter"}2020-08-20https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-carfilzomib-and-daratumumab-dexamethasone-multiple-myeloma
"belantamab mafodotin-blmf""31%""\u22656 months""Not met primary endpoint for superior PFS in DREAMM-3 trial""NA""NA""NA""DREAMM-2 (NCT 03525678), an open-label, multicenter trial with recommended dose of 2.5 mg\/kg"["keratopathy","decreased visual acuity","nausea","blurred vision","pyrexia","infusion-related reactions","fatigue"]"Changes in corneal epithelium causing severe vision loss and corneal ulcer""2.5 mg\/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks"2020-08-05https://fda.gov/drugs/resources-information-approved-drugs/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma
"tafasitamab-cxix (MONJUVI)""55%""21.7 months""NA""NA""37%""18%""L-MIND (NCT02399085), open label, multicenter single-arm trial in 81 patients"["neutropenia","fatigue","anemia","diarrhea","thrombocytopenia","cough","pyrexia","peripheral edema","respiratory tract infection","decreased appetite"]"NA""12 mg\/kg as an intravenous infusion"2020-07-31https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma
"atezolizumab (Tecentriq, Genentech, Inc.)""NA""NA"{"atezolizumab arm":"15.1 months (95% CI: 11.4, 18.4)","placebo arm":"10.6 months (95% CI: 9.3, 12.7)","HR":"0.78","p-value":"0.0249"}"NA""NA""NA"{"Trial name":"IMspire150","Trial ID":"NCT02908672","Patient count":"514","Regimen":"atezolizumab 840 mg IV every 2 weeks + cobimetinib 60 mg orally daily + vemurafenib 720 mg orally twice daily vs placebo + cobimetinib 60 mg orally daily + vemurafenib 960 mg orally twice daily"}["rash","musculoskeletal pain","nausea","fatigue","hepatotoxicity","pyrexia","nausea","pruritus","edema","stomatitis","hypothyroidism","photosensitivity reaction"]"NA"{"atezolizumab":"840 mg every 2 weeks","cobimetinib":"60 mg orally daily (21 days on\/7 days off)","vemurafenib":"720 mg orally twice daily"}2020-07-30https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-braf-v600-unresectable-or-metastatic-melanoma
"brexucabtagene autoleucel (TECARTUS)""87%""Not reached""NA""NA""62%""NA""ZUMA-2 (NCT02601313), single-arm trial of 74 patients with relapsed or refractory MCL"["anemia","neutropenia","thrombocytopenia","hypotension","hypophosphatemia","encephalopathy","leukopenia","hypoxia","pyrexia","hyponatremia","hypertension","infection - pathogen unspecified","pneumonia","hypocalcemia","lymphopenia"]"Risk of cytokine release syndrome (CRS) and neurologic toxicities""Single intravenous infusion of 2 x 10^6 CAR-positive viable T cells per kg body weight (max 2 x 10^8 CAR-positive viable T cells), preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy."2020-07-24https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-mantle-cell-lymphoma
"INQOVI""Not available""Not available""Not available""Not available""18%""NA"{"Trial 01-B":{"CR rate":"18%","Median duration of CR":"8.7 months","Transfusion independence rate":"49% (RBC and\/or platelet transfusions)"},"Trial 02":{"CR rate":"21%","Median duration of CR":"7.5 months","Transfusion independence rate":"53% (RBC and\/or platelet transfusions)"}}["fatigue","constipation"]"NA""1 tablet (35 mg decitabine and 100 mg cedazuridine) taken orally on an empty stomach once daily on days 1 through 5 of each 28\u2011day cycle"2020-07-07https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-myelodysplastic-syndromes
"avelumab (BAVENCIO, EMD Serono, Inc.)""NA""NA""NA"{"All patients":{"Median":"21.4 months","HR":"0.69","95% CI":"0.56, 0.86","p-value":"0.001"},"PD-L1-positive tumors":{"HR":"0.56","95% CI":"0.40, 0.79","p-value":"<0.001"},"PD-L1-negative tumors":{"HR":"0.85","95% CI":"0.62, 1.18"}}"NA""NA"{"Trial name":"JAVELIN Bladder 100","Trial ID":"NCT02603432","Patient enrollment":"700","Treatment groups":{"Avelumab + BSC":"21.4 months OS","BSC alone":"14.3 months OS"}}["fatigue","musculoskeletal pain","urinary tract infection","rash"]"One patient died from sepsis and 28% of patients had serious adverse reactions.""800 mg administered as an intravenous infusion over 60 minutes every 2 weeks"2020-06-30https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment
"pembrolizumab (KEYTRUDA, Merck & Co.)""NA""NA""16.5 months (95% CI: 5.4, 32.4) in the pembrolizumab arm and 8.2 months (95% CI: 6.1, 10.2) in the chemotherapy arm (HR 0.60, 95% CI 0.45,0.80; two-sided p-value=0.0004)""NA""NA""NA""KEYNOTE\u2011177 (NCT02563002), a multicenter, international, open-label, active-controlled, randomized trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. Determination of MSI or MMR tumor status was made locally using PCR or IHC. Patients were randomized to receive pembrolizumab 200 mg every 3 weeks or investigator\u2019s choice of mFOLFOX6\/FOLFIRI \u00b1 bevacizumab or cetuximab given intravenously every 2 weeks. Patients randomized to chemotherapy were offered pembrolizumab at the time of disease progression."["fatigue","musculoskeletal pain","decreased appetite","pruritus","diarrhea","nausea","rash","pyrexia","cough","dyspnea","constipation","pain","abdominal pain"]"NA""200 mg every 3 weeks or 400 mg every 6 weeks"2020-06-29https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer
"null""null""null""null""null""null""null""null""null""null""null"2020-06-29https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-combination-pertuzumab-trastuzumab-and-hyaluronidase-zzxf-her2-positive-breast-cancer
"pembrolizumab (KEYTRUDA, Merck & Co., Inc.)""34%""Not reached (range: 2.7, 13.1+ months)""NA""NA""NA""NA""KEYNOTE-629 (NCT03284424), a multicenter, multi-cohort, non-randomized, open-label trial"["fatigue","musculoskeletal pain","decreased appetite","pruritus","diarrhea","nausea","rash","pyrexia","cough","dyspnea","constipation","pain","abdominal pain"]"Immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions""200 mg every 3 weeks or 400 mg every 6 weeks"2020-06-24https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-cutaneous-squamous-cell-carcinoma
"selinexor (XPOVIO, Karyopharm Therapeutics)""29%""38%""NA""NA""13%""16%""SADAL (KCP-330-009; NCT02227251), a multicenter, single-arm, open-label trial in patients with DLBCL after 2 to 5 systemic regimens. Patients received selinexor 60 mg orally on days 1 and 3 of each week."["fatigue","nausea"]["thrombocytopenia","neutropenia","gastrointestinal toxicity"]"60 mg taken orally on days 1 and 3 of each week with antiemetic prophylaxis"2020-06-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma
"TAZVERIK"{"EZH2 mutant FL":"69%","EZH2 wild-type FL":"34%"}{"EZH2 mutant FL":"10.9 months","EZH2 wild-type FL":"13 months"}"NA""NA"{"EZH2 mutant FL":"12%","EZH2 wild-type FL":"4%"}{"EZH2 mutant FL":"57%","EZH2 wild-type FL":"30%"}"Based on Study E7438-G000-101 (NCT01897571) in patients with histologically confirmed FL after at least 2 prior systemic therapies."["Fatigue","Upper respiratory tract infection"]"Secondary malignancies""800 mg taken orally twice daily with or without food"2020-06-18https://fda.gov/drugs/fda-granted-accelerated-approval-tazemetostat-follicular-lymphoma
"pembrolizumab (KEYTRUDA)""29%""Not reached""NA""NA""4%""25%""Prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic TMB-H solid tumors enrolled in a multicenter, non-randomized, open-label trial, KEYNOTE-158 (NCT02628067)"["fatigue","musculoskeletal pain","decreased appetite","pruritus","diarrhea","nausea","rash","pyrexia","cough","dyspnea","constipation","pain","abdominal pain"]"Immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions""200 mg every 3 weeks for adult solid tumors; 2 mg\/kg (up to a max of 200 mg) every 3 weeks for pediatric patients solid tumors"2020-06-16https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors
"MYLOTARG""NA""NA""NA""NA""NA""NA"{"Study Name":"AAML0531","Study Identifier":"NCT00372593","Patient Population":"1,063 patients with newly-diagnosed AML ages 0 to 29 years","Intervention":["5-cycle chemotherapy","gemtuzumab ozogamicin (3 mg\/m^2) administered once on day 6 in Induction 1 and once on day 7 in Intensification 2"],"EFS Hazard Ratio":0.84,"Percentage of patients free of induction failure, relapse, or death at five years":{"Gemtuzumab ozogamicin + chemotherapy arm":"48% (95% CI: 43%-52%)","Chemotherapy alone arm":"40% (95% CI: 36%-45%)"}}["Infection","Febrile neutropenia","Decreased appetite","Hyperglycemia","Mucositis","Hypoxia","Hemorrhage","Increased transaminase","Diarrhea","Nausea","Hypotension"]"NA""3 mg\/m^2 gemtuzumab ozogamicin"2020-06-16https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-gemtuzumab-ozogamicin-cd33-positive-aml-pediatric-patients
"lurbinectedin(ZEPZELCA)""35%""5.3 months""NA""NA""NA""NA""PM1183-B-005-14 trial (Study B-005; NCT02454972), 105 patients with metastatic SCLC"["myelosuppression","fatigue","increased creatinine","increased alanine aminotransferase","increased glucose","nausea","decreased appetite","musculoskeletal pain","decreased albumin","constipation","dyspnea","decreased sodium","increased aspartate aminotransferase","vomiting","cough","decreased magnesium","diarrhea"]"NA""3.2 mg\/m^2 every 21 days"2020-06-15https://fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
"nivolumab (OPDIVO, Bristol-Myers Squibb Co.)""19.3%"{"nivolumab":"6.9 months","taxane chemotherapy":"3.9 months"}"No improvement demonstrated"{"nivolumab":{"median":"10.9 months","confidence_interval":"9.2, 13.3","HR":"0.77","p_value":"0.0189"},"taxane chemotherapy":{"median":"8.4 months","confidence_interval":"7.2, 9.9"},"benefit_observed":"Regardless of tumor PD-L1 expression level"}"NA""NA"{"trial_name":"ATTRACTION-3","trial_identifier":"NCT02569242","design":"Multicenter, randomized (1:1), active-controlled, open-label trial","patient_count":"419"}["rash","decreased appetite","diarrhea","constipation","musculoskeletal pain","upper respiratory tract infection","cough","pyrexia","pneumonia","anemia","fatigue","pruritus","nausea","hypothyroidism"]"NA"{"nivolumab":{"every_2_weeks":"240 mg","every_4_weeks":"480 mg"}}2020-06-10https://fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma
"ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib"{"ramucirumab plus erlotinib arm":"76%","placebo plus erlotinib arm":"75%"}{"ramucirumab plus erlotinib arm":"18.0 months","placebo plus erlotinib arm":"11.1 months"}{"ramucirumab plus erlotinib arm":"19.4 months","placebo plus erlotinib arm":"12.4 months","Hazard Ratio":"0.59","p-value":"<0.0001"}{"HR":"0.83","Confidence Interval":"0.53, 1.30"}"NA""NA""RELAY (NCT02411448)"["infections","hypertension","stomatitis","proteinuria","alopecia","epistaxis","peripheral edema"]"NA""10 mg\/kg every 2 weeks"2020-05-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-plus-erlotinib-first-line-metastatic-nsclc
["atezolizumab","bevacizumab"][{"atezolizumab_plus_bevacizumab":"28%"},{"sorafenib":"12%"}]"NA"[{"atezolizumab_plus_bevacizumab":"6.8 months"},{"sorafenib":"4.3 months"}][{"atezolizumab_plus_bevacizumab":"Not reached"},{"sorafenib":"13.2 months"}]"NA""NA""IMbrave150 (NCT03434379) - multicenter, international, open-label, randomized trial"["Hypertension","Fatigue","Proteinuria"]"NA"{"atezolizumab":"1,200 mg every 3 weeks","bevacizumab":"15 mg\/kg on the same day every 3 weeks"}2020-05-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-plus-bevacizumab-unresectable-hepatocellular-carcinoma
"null""null""null""null""null""null""null""null""null""null""null"2020-05-26https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-plus-ipilimumab-and-chemotherapy-first-line-treatment-metastatic-nsclc
"brigatinib (ALUNBRIG)""74%""NA""24 months""NA""NA""NA""ALTA 1L (NCT02737501), randomized trial in ALK-positive NSCLC patients"["diarrhea","fatigue","nausea","rash","cough","myalgia","headache","hypertension","vomiting","dyspnea"]"NA""90 mg orally once daily for the first 7 days; then increase to 180 mg orally once daily"2020-05-22https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-brigatinib-alk-positive-metastatic-nsclc
"olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP)""33%""NA""7.4 months vs 3.6 months (HR 0.34; 95% CI: 0.25, 0.47; p<0.0001)""19.1 months vs. 14.7 months (HR 0.69; 95% CI: 0.50, 0.97, p=0.0175)""NA""NA""Investigated in PROfound trial (NCT02987543) with significant improvement in rPFS and OS compared to investigator's choice"["anemia","nausea","fatigue","decreased appetite","diarrhea","vomiting","thrombocytopenia","cough","dyspnea"]"Venous thromboembolic events, including pulmonary embolism (7% olaparib vs 3.1% enzalutamide or abiraterone)""300 mg taken orally twice daily, with or without food"2020-05-19https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-hrr-gene-mutated-metastatic-castration-resistant-prostate-cancer
"atezolizumab (TECENTRIQ\u00ae, Genentech Inc.)""38%""NA"{"atezolizumab arm":"8.1 months","chemotherapy arm":"5.0 months"}{"atezolizumab arm":"20.2 months","chemotherapy arm":"13.1 months","Hazard Ratio":"0.59","P-value":"0.0106"}"NA""NA""IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in patients with stage IV NSCLC whose tumors express PD-L1 (TC \u2265 1% or IC \u2265 1%), who had received no prior chemotherapy for metastatic disease."["fatigue\/asthenia"]"NA"["840 mg every 2 weeks","1200 mg every 3 weeks","1680 mg every 4 weeks, administered intravenously over 60 minutes"]2020-05-18https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-first-line-treatment-metastatic-nsclc-high-pd-l1-expression
"ripretinib (QINLOCK)"{"ripretinib":9,"placebo":0}{"ripretinib":"Not provided","placebo":"Not provided"}{"ripretinib":"6.3 months (95% CI: 4.6, 6.9)","placebo":"1.0 month (95% CI: 0.9, 1.7)"}{"ripretinib":"15.1 months (95% CI: 12.3, 15.1)","placebo":"6.6 months (95% CI: 4.1, 11.6)"}"NA""NA"{"trial":"INVICTUS (NCT03353753)","patient count":129,"previous kinase inhibitors":"imatinib, sunitinib, and regorafenib","endpoint":{"PFS":"Blinded independent central review (BICR)","ORR":"BICR","OS":"Not evaluated for statistical significance"}}["alopecia","fatigue","nausea","abdominal pain","constipation","myalgia","diarrhea","decreased appetite","palmar-plantar erythrodysesthesia","vomiting"]["new primary cutaneous malignancies","hypertension","cardiac dysfunction"]"150 mg orally once daily with or without food"2020-05-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ripretinib-advanced-gastrointestinal-stromal-tumor
"Rucaparib (RUBRACA)""44%""1.7-24+ months""NA""NA""NA""NA""TRITON2 (NCT02952534)"["fatigue","nausea","anemia","increased ALT\/AST","decreased appetite","rash","constipation","thrombocytopenia","vomiting","diarrhea"]"NA""600 mg orally twice daily with or without food"2020-05-15https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-rucaparib-brca-mutated-metastatic-castration-resistant-prostate
"null""null""null""null""null""null""null""null""null""null""null"2020-05-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-plus-ipilimumab-first-line-mnsclc-pd-l1-tumor-expression-1
"POMALYST"{"HIV-positive patients":"67%","HIV-negative patients":"80%"}{"HIV-positive patients":"12.5 months","HIV-negative patients":"10.5 months"}"NA""NA""NA""NA"{"Trial name":"Study 12-C-0047","Trial type":"Open-label, single-arm clinical trial","Trial sponsor":"National Cancer Institute","Number of patients":28,"Dosage administered":"5 mg of pomalidomide orally once daily on days 1 through 21 of each 28-day cycle"}["Decreased absolute neutrophil count or white blood cells","Elevated creatinine or glucose","Rash","Constipation","Fatigue","Decreased hemoglobin, platelets, phosphate, albumin, or calcium","Increased ALT","Nausea","Diarrhea"]"NA""5 mg once daily taken orally with or without food on days 1 through 21 of each 28\u2011day cycle"2020-05-14https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pomalidomide-kaposi-sarcoma
"null""null""null""null""null""null""null""null""null""null""null"2020-05-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-plus-bevacizumab-maintenance-treatment-ovarian-fallopian-tube-or-primary
["selpercatinib (RETEVMO, Eli Lilly and Company)"]"64% (NSCLC), 69% (RET-mutant MTC), 73% (RET fusion-positive thyroid cancer)""81% lasting 6 months or longer (NSCLC), 76% lasting 6 months or longer (RET-mutant MTC), 61-87% lasting 6 months or longer (RET fusion-positive thyroid cancer)""NA""NA""NA""NA""Multicenter, open-label, multi-cohort clinical trial (LIBRETTO-001)"["increased aspartate aminotransferase","increased alanine aminotransferase"]"NA""Weight-based\u2014120 mg for patients less than 50 kg, and 160 mg for those 50 kg or greater. Selpercatinib is taken orally twice daily with or without food; or with food when co-administered with a proton pump inhibitor."2020-05-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-lung-and-thyroid-cancers-ret-gene-mutations-or-fusions
"capmatinib"{"Treatment-na\u00efve patients":"68%","Previously treated patients":"41%"}{"Treatment-na\u00efve patients":"12.6 months","Previously treated patients":"9.7 months"}"NA""NA""NA""NA""GEOMETRY mono-1 trial (NCT02414139)"["peripheral edema","nausea","fatigue","vomiting","dyspnea","decreased appetite"]["interstitial lung disease","hepatotoxicity","photosensitivity","embryo-fetal toxicity"]"400 mg orally twice daily with or without food"2020-05-06https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-capmatinib-metastatic-non-small-cell-lung-cancer
"daratumumab and hyaluronidase-fihj (DARZALEX FASPRO)""41.1%""NA""NA""NA""NA""NA"{"Trial 1":{"Drug combination":"daratumumab and hyaluronidase-fihj monotherapy","Trial name":"COLUMBA (NCT03277105)","ORR":"41.1%","PK endpoint":"maximum Ctrough"},"Trial 2":{"Drug combination":"D-VMP","Trial name":"PLEIADES (NCT03412565)","ORR":"88.1%"},"Trial 3":{"Drug combination":"D-Rd","Trial name":"Unnamed trial","ORR":"90.8%"}}["upper respiratory tract infection","fatigue","constipation","nausea","pyrexia","peripheral sensory neuropathy","diarrhea","cough","insomnia","vomiting","back pain","muscle spasms","pneumonia","dyspnea"]"NA""1,800 mg daratumumab and 30,000 units hyaluronidase administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to recommended schedule"2020-05-01https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma
"niraparib (ZEJULA, GlaxoSmithKline)""NA""NA"{"Homologous Recombination Deficient Population":{"Median":"21.9 months","95% CI":"19.3, NE","HR":"0.43","p-value":"<0.0001"},"Overall Population":{"Median":"13.8 months","95% CI":"11.5, 14.9","HR":"0.62","p-value":"<0.0001"}}"NA""NA""NA"{"Trial Name":"PRIMA (NCT02655016)","Study Design":"Double-blind, placebo-controlled","Number of Patients":733,"Endpoints":"PFS"}["thrombocytopenia","anemia","nausea","fatigue","neutropenia","constipation","musculoskeletal pain","leukopenia","headache","insomnia","vomiting","dyspnea","decreased appetite","dizziness","cough","hypertension","AST\/ALT elevation","acute kidney injury"]"NA"{"Less than 77 kg or platelet count < 150,000\/\u03bcL":"200 mg once daily","Greater than or equal to 77 kg and platelet count >= 150,000\/\u03bcL":"300 mg once daily"}2020-04-29https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer
"KEYTRUDA""39% (95% CI: 24, 55)""NA""NA""NA""NA""NA""Cohort B of Study KEYNOTE-555 was an international, single-arm, multi-center study that enrolled 101 patients with advanced or metastatic melanoma who had not received prior PD-1, PD-L1, or CTLA-4 inhibitors (other than CTLA-4 inhibitors in the adjuvant setting). The ORR was 39% (95% CI: 24, 55) in the first 44 patients enrolled in KEYNOTE-555."["NA","NA"]"NA""400 mg every six weeks in addition to the current 200 mg every three weeks dosing regimen"2020-04-28https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-pembrolizumab
"sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.)""33.3%""7.7 months""NA""NA""NA""NA""IMMU-132-01 (NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer (mTNBC) who received at least two prior treatments for metastatic disease"["nausea","neutropenia","diarrhea","fatigue","anemia","vomiting","alopecia","constipation","rash","decreased appetite","abdominal pain"]"severe neutropenia and diarrhea""10 mg\/kg administered by intravenous infusion administered on days 1 and 8 every 21 days until disease progression or unacceptable toxicity"2020-04-22https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer
"ibrutinib (IMBRUVICA)""NA""NA""HR 0.34; 95% CI: 0.22, 0.52; p<0.0001""NA""NA""NA""E1912 trial (NCT02048813), 2:1 randomized, multicenter trial of ibrutinib with rituximab vs FCR in 529 adult patients 70 years or younger with previously untreated CLL or SLL"["thrombocytopenia","diarrhea","fatigue","musculoskeletal pain","neutropenia","rash","anemia","bruising","nausea"]"NA""ibrutinib at 420 mg once daily orally with water, rituximab administered at specific dosages on specific days in each cycle"2020-04-21https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-ibrutinib-plus-rituximab-chronic-lymphocytic-leukemia
"pemigatinib (PEMAZYRE, Incyte Corporation)""36%""9.1 months""NA""NA""3""NA""FIGHT-202 (NCT02924376), a multicenter open-label single-arm trial, in 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after at least one prior therapy and had an FGFR2 gene fusion or rearrangement. Patients received pemigatinib, 13.5 mg orally, once daily for 14 consecutive days, followed by 7 days off therapy."["hyperphosphatemia","alopecia","diarrhea","nail toxicity","fatigue","dysgeusia","nausea","constipation","stomatitis","dry eye","dry mouth","decreased appetite","vomiting","arthralgia","abdominal pain","hypophosphatemia","back pain","dry skin"]"Ocular toxicity and hyperphosphatemia""13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles"2020-04-20https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pemigatinib-cholangiocarcinoma-fgfr2-rearrangement-or-fusion
"TUKYSA"{"Tucatinib arm":"40.6%","Control arm":"22.8%"}"NA"{"Tucatinib arm":"7.8 months","Control arm":"5.6 months"}{"Tucatinib arm":"21.9 months","Control arm":"17.4 months"}"NA""NA""HER2CLIMB trial (NCT02614794) enrolling 612 patients"["Diarrhea","Palmar-plantar erythrodysesthesia"]"Severe diarrhea and hepatotoxicity""300 mg taken orally twice a day in combination with trastuzumab and capecitabine until disease progression or unacceptable toxicity"2020-04-17https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tucatinib-patients-her2-positive-metastatic-breast-cancer
"mitomycin (JELMYTO, UroGen Pharma)""NA""NA""NA""NA""41 patients (58%) achieved a CR three months following treatment initiation""NA""OLYMPUS (NCT02793128), an ongoing, single-arm, multicenter trial enrolling 71 patients with treatment-na\u00efve or recurrent low-grade non-invasive UTUC with at least one measurable papillary tumor located above the ureteropelvic junction"["ureteric obstruction","flank pain","urinary tract infection","hematuria","renal dysfunction","fatigue","nausea","abdominal pain","dysuria","vomiting"]"Ureteric obstruction occurred in 58% of those receiving JELMYTO and required ureteral stent placement in 88% of these patients""4 mg per mL instilled via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not exceeding 15 mL (60 mg mitomycin)"2020-04-15https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-low-grade-upper-tract-urothelial-cancer
"selumetinib (KOSELUGO)""66% (n=33; 95% CI: 51,79)""82% of responders had sustained responses lasting at least 12 months""NA""NA""All patients had a partial response""NA""Efficacy of selumetinib was investigated in SPRINT (NCT01362803), a National Cancer Institute (NCI) sponsored, open-label, multicenter, single-arm trial in pediatric patients with NF1 and a measurable target PN that could not be surgically removed without risk of substantial morbidity."["vomiting","rash","abdominal pain","diarrhea","nausea","dry skin","fatigue","musculoskeletal pain","fever","acne","stomatitis","headache","paronychia","pruritus"]["cardiomyopathy","ocular toxicity including retinal vein occlusion, retinal pigment epithelial detachment and impaired vision","increased creatinine phosphokinase"]"25 mg\/m2 orally twice a day on an empty stomach until disease progression or unacceptable toxicity"2020-04-10https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-neurofibromatosis-type-1-symptomatic-inoperable-plexiform-neurofibromas
"null""null""null""null""null""null""null""null""null""null""null"2020-04-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-combination-cetuximab-metastatic-colorectal-cancer-braf-v600e-mutation
"luspatercept-aamt (REBLOZYL)""NA""NA""NA""NA""NA""NA"{"Trial name":"MEDALIST trial","Trial ID":"NCT02631070","Patient population":"229 patients with IPSS-R very low, low, or intermediate-risk myelodysplastic syndromes who had ring sideroblasts and required RBC transfusions","Intervention":"luspatercept-aamt vs. placebo","Endpoint":"Proportion of patients who were RBC-transfusion independent"}["fatigue","headache","musculoskeletal pain","arthralgia","dizziness\/vertigo","nausea","diarrhea","cough","abdominal pain","dyspnea","hypersensitivity"]"NA""1 mg\/kg once every 3 weeks by subcutaneous injection; Review hemoglobin results prior to each administration"2020-04-03https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-luspatercept-aamt-anemia-adults-mds
"durvalumab""68%""null""5.1 months""13.0 months""null""null""CASPIAN trial (NCT03043872)"["nausea","fatigue\/asthenia","alopecia"]"null""1500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single agent"2020-03-30https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-extensive-stage-small-cell-lung-cancer
["nivolumab","ipilimumab"]"33%""4.6 to 30.5+ months""NA""NA"412"Cohort 4 of CHECKMATE-040, NCT01658878"["fatigue","diarrhea","rash","pruritus","nausea","musculoskeletal pain","pyrexia","cough","decreased appetite","vomiting","abdominal pain","dyspnea","upper respiratory tract infection","arthralgia","headache","hypothyroidism","decreased weight","dizziness"]"NA"{"Initial doses":{"nivolumab":"1 mg\/kg","ipilimumab":"3 mg\/kg"},"Maintenance doses":{"nivolumab":["240 mg every 2 weeks","480 mg every 4 weeks"]}}2020-03-10https://fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-nivolumab-and-ipilimumab-combination-hepatocellular-carcinoma
"isatuximab-irfc""NA""NA"{"median":"11.53 months","95% CI":"8.94-13.9"}"NA""NA""NA"{"study":"ICARIA-MM","patients":"307","randomization":"1:1","treatments":{"Isa-Pd":{"patients":"154","PFS HR":"0.596","PFS CI":"0.44-0.81","p-value":"0.0010"},"Pd":{"patients":"153"}}}["neutropenia","infusion-related reactions","pneumonia","upper respiratory tract infection","diarrhea"]"NA"{"isatuximab-irfc":{"dose":"10 mg\/kg","administration":"intravenous infusion","frequency":"weekly for 4 weeks followed by every 2 weeks"},"in combination with":["pomalidomide","dexamethasone"],"duration":"until disease progression or unacceptable toxicity"}2020-03-02https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-multiple-myeloma-0
"neratinib (NERLYNX)""32.8% vs 26.7%""8.5 vs 5.6 months""5.6 vs 5.5 months""21 vs 18.7 months""NA""NA""NALA (NCT01808573), randomized trial with 621 patients"["diarrhea","nausea"]"NA""neratinib 240 mg orally once daily + capecitabine 750 mg\/m^2 twice daily on days 1-14 of a 21-day cycle"2020-02-25https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-neratinib-metastatic-her2-positive-breast-cancer
"tazemetostat (TAZVERIK, Epizyme, Inc.)""15%""67% of responders had responses lasting 6 months or longer""NA""NA""1.6%""13%""Single-arm cohort (Cohort 5) of Study EZH-202 (NCT02601950) in patients with metastatic or locally advanced epithelioid sarcoma"["pain","fatigue","nausea","decreased appetite","vomiting","constipation"]"NA""800 mg taken orally twice daily with or without food"2020-01-23https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-advanced-epithelioid-sarcoma
"avapritinib (AYVAKITTM)""84%""Not reached""NA""NA""7%""77%""NAVIGATOR (NCT02508532) - multi-center, single-arm, open-label trial enrolling 43 patients with GIST harboring a PDGFRA exon 18 mutation; Major outcome measure: ORR based on independent radiological review using modified RECIST 1.1 criteria."["Edema","Nausea"]"Dizziness""300 mg orally once daily on an empty stomach, at least one hour before and two hours after a meal"2020-01-09https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-avapritinib-gastrointestinal-stromal-tumor-rare-mutation
"pembrolizumab (KEYTRUDA, Merck & Co. Inc.)""NA""NA""NA""NA""41% (95% CI: 31, 51)""NA""KEYNOTE-057 (NCT, a multicenter, single-arm trial that enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors."["fatigue","diarrhea","rash","pruritis","musculoskeletal pain","hematuria","cough","arthralgia","nausea","constipation","urinary tract infection","peripheral edema","hypothyroidism","nasopharyngitis"]"NA""200 mg every 3 weeks"2020-01-08https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer
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