Bristol Myers Squibb and 2seventy bio, Inc. announced that a notice was published in the Federal Register that the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, to review data supporting the supplemental Biologics License Application (sBLA) for Abecma®(idecabtagene vicleucel) 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 (OS) from the study. Final PFS data and interim OS data from the KarMMa-3 study were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023.

Abecma was recently approved in Japan for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody based on the KarMMa-3 study, making it the first CAR T cell therapy to receive regulatory approval for use in earlier lines of therapy for patients with relapsed and refractory multiple myeloma. Abecma also received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies.