Drug Approvals

FDA Approvals

FDA approves rituximab plus chemotherapy for pediatric cancer indications (12/2/21)

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma (11/30/21)

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor (11/22/21)

FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia (10/29/21)

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer (10/15/21)

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer (10/13/21)

FDA approves abemaciclib with endocrine therapy for early breast cancer (10/12/21)

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (10/1/21)

FDA approves ruxolitinib for chronic graft-versus-host disease (9/22/21)

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer (9/20/21)

FDA approves cabozantinib for differentiated thyroid cancer (9/17/21)

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations (9/15/21)

FDA approves zanubrutinib for Waldenström’s macroglobulinemia (8/31/21)

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma (8/25/21)

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma (8/19/21)

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors (8/17/21)

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease (8/13/21)

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer (7/26/21)

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma (7/21/21)

FDA approves belumosudil for chronic graft-versus-host disease (7/16/21)

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma (7/9/21)

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer (7/9/21)

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma (6/30/21)

FDA approves avapritinib for advanced systemic mastocytosis (6/16/21)

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma (5/28/21)

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC (5/28/21)

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer (5/21/21)

FDA approves nivolumab for resected esophageal or GEJ cancer (5/20/21)

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer (5/5/21)

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma (4/23/21)

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer (4/22/21)

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma (4/16/21)

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer (4/13/21)

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer (4/7/21)

FDA approves new dosing regimen for cetuximab (4/6/21)

FDA approves isatuximab-irfc for multiple myeloma (3/31/21)

FDA approves idecabtagene vicleucel for multiple myeloma (3/29/21)

FDA approves pembrolizumab for esophageal or GEJ carcinoma (3/22/21)

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma (3/10/21)

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma (3/5/21)

FDA approves lorlatinib for metastatic ALK-positive NSCLC (3/3/21)

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma (2/26/21)

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression (2/22/21)

FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma (2/9/21)

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma (2/5/21)

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma (2/5/21)

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer (2/3/21)

FDA approves nivolumab plus cabozantinib for advanced renal /cell carcinoma (1/22/21)

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (1/14/21)

FDA approves relugolix for advanced prostate cancer (12/18/20)

FDA approves selinexor for refractory or relapsed multiple myeloma (12/18/20)

FDA approves margetuximab for metastatic HER2-positive breast cancer (12/16/20)

FDA approves pralsetinib for RET-altered thyroid cancers (12/1/20)

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow (11/24/20)

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer (11/13/20)

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi (10/23/20)

FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia (10/16/20)

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma (10/2/20)

FDA approves pralsetinib for lung cancer with RET gene fusions/ (9/4/20)

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia (9/1/20)

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma (8/20/20)

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma (8/5/20)

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma (7/31/20)

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma (7/30/20)

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma (7/24/20)

FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes (7/7/20)

FDA approves avelumab for urothelial carcinoma maintenance treatment (6/30/20)

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer (6/29/20)

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer (6/29/20)

FDA approves pembrolizumab for cutaneous squamous cell carcinoma (6/24/20)

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma (6/22/20)

FDA granted accelerated approval to tazemetostat for follicular lymphoma (6/18/20)

FDA approves pembrolizumab for adults and children with TMB-H solid tumors (6/16/20)

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients (6/16/20)

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer (6/15/20)

FDA approves nivolumab for esophageal squamous cell carcinoma (6/10/20)

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC (5/29/20)

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC (5/26/20)

FDA approves brigatinib for ALK-positive metastatic NSCLC (5/22/20)

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer (5/19/20)

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression (5/18/20)

FDA approves ripretinib for advanced gastrointestinal stromal tumor (5/15/20)

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer (5/15/20)

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (5/15/20)

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma (5/14/20)

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers (5/8/20)

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions (5/8/20)

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer (5/6/20)

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma (5/1/20)