FDA Approvals, News & Updates
On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication. Read More ›
On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read More ›
On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA granted sacituzumab govitecan priority review and a fast-track designation for this indication. Read More ›
On April 16, 2021, the FDA approved nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, in combination with certain types of chemotherapy, for the initial treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The FDA granted nivolumab priority review and an orphan drug designation for this indication. Read More ›
On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen–directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy. Idecabtagene vicleucel is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. The FDA granted idecabtagene vicleucel orphan drug and breakthrough therapy designations. Read More ›
On April 22, 2021, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a previous platinum-containing regimen. The FDA granted dostarlimab priority review and a breakthrough therapy designation for this indication. Read More ›
On April 23, 2021, the FDA approved loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics), a CD19-directed antibody–drug conjugate, for the treatment of adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. The FDA granted loncastuximab tesirine priority review and an orphan drug designation for this indication. Read More ›
On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb), a new chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma. Read More ›
On February 5, 2021, the FDA granted accelerated approval to umbralisib (Ukoniq; TG Therapeutics), a dual inhibitor of PI3Kδ and CK1ε, for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received ≥1 previous anti-CD20–based regimens, and adult patients with relapsed or refractory follicular lymphoma who have received ≥3 previous lines of systemic therapy. Read More ›
On February 3, 2021, the FDA accelerated the approval of tepotinib (Tepmetko; EMD Serono), an oral MET kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) who harbor MET exon 14 skipping alterations. Read More ›