FDA Approvals

The FDA granted accelerated approval to lisocabtagene maraleucel for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK...

The FDA has approved mirvetuximab soravtansine for previously treated patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected by an FDA-approved test.

On March 19, 2024, the US FDA granted accelerated approval to ponatinib with chemotherapy for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The FDA granted accelerated approval for zanubrutinib with obinutuzumab treatment for patients with relapsed or refractory follicular lymphoma, following 2 or more lines of systemic therapy.

The FDA has approved amivantamab for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 mutations, as detected by an FDA-approved test.

On February 20, 2024, the FDA granted approval for teclistamab administered with biweekly dosing for patients with relapsed/refractory multiple myeloma.

Based on results from the phase 3 FLAURA 2 trial, the FDA has approved osimertinib plus platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R...

Based on updated results from the phase 2 VISION trial, the FDA has approved tepotinib for patients with metastatic non-small cell lung cancer harboring MET exon 14 skipping alterations.

The US Food and Drug Association has granted approval to irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin for the treatment of patients with metastatic pancreatic adenocarcinoma in the first-line setting.

Based on results from cohort 1 of the BLC3001 study, the FDA has approved erdafitinib for patients with locally advanced/metastatic urothelial carcinoma harboring FGFR3 alterations.