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Bristol Myers (BMY), TSVT CAR T-Cell Therapy to Face FDA's ODAC
BMYBristol-Myers Squibb(BMY) Zacks Investment Research·2024-02-07 01:05

Bristol Myers Squibb (BMY) and its partner 2seventy bio, Inc. (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 Mar 15, 2024, to review data supporting the supplemental biologics license application (sBLA) for Abecma (idecabtagene vicleucel).The sBLA is seeking label expansion of Abecma for triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal p ...