Bristol Myers and 2seventy Bio’s application for Abecma to be reviewed by FDA

Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) announced that a notice was published in the Federal Register that the FDA will convene a virtual meeting of the Oncologic Drugs Advisory Committee – ODAC – on March 15, to review data supporting the supplemental Biologics License Application for Abecma for triple-class exposed relapsed or refractory multiple myeloma, based on results from the pivotal Phase 3 KarMMa-3 study. The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival from the study. Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Abecma was recently approved in Japan for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies. Abecma also received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency for patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies. Regulatory applications for Abecma for this patient population remain under review with the EMA and Swissmedic.