U.S. Food and Drug Administration Approves Bristol Myers Squibb’s & bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

Mar 29, 2021

Posted by Bristol Myers Squibb

Abecma is a first-in-class BCMA-directed personalized immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma1

In the pivotal KarMMa trial, the majority (72%) of patients achieved rapid, deep and durable responses1

Safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that are mostly low-grade with early onset and resolution1

Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.1 As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.2 Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities (NT), Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), and Prolonged Cytopenia.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210326005507/en/


  1. Abecma Prescribing Information. Bristol Myers Squibb; March 2021.
  2. Cho, S.F., Anderson, K., Tai, Y.T. (2018). Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Frontiers in Immunology, (9)1821.1-15. https://www.frontiersin.org/article/10.3389/fimmu.2018.01821.

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