Bristol Myers Squibb (BMY)

[DewDiligence]

BMY/BLUE—FDA_approves Abecma—(f/k/a_bb2121/ide-cel)—BCMA_CAR-T_for_MM:

https://investors.bms.com/iframes/press-releases/press-release-details/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-and-bluebird-bios-Abecma-idecabtagene-vicleucel-the-First-Anti-BCMA-CAR-T-Cell-Therapy-for-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

Bristol Myers Squibb and bluebird bio, Inc. 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 10^6 CAR-positive T cells. 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.

Yesterday was the PDUFA date.

FDA approval of ide-cel by 3/31/21 was one of the three requirements for the $9/sh Celgene CVR to pay off, but this became moot when a distinct CAR-T, liso-cel was not approved by its 12/31/20 deadline (#msg-160628371). The FDA approved liso-cel for DLBCL with the brand name, Breyanzi on 2/5/21 (#msg-161552697).