Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
BLA submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient population with relapsed and refractory multiple myeloma PRINCETON, NJ. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.The submission is based on results from the pivotal Phase 2 KarMMa study. The KarMMa study evaluated the efficacy and safety of ide-cel in heavily pre-treated patients with relapsed and refractory multip
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