BLUE - Bristol Myers and Bluebird bio wins FDA approval for ide-cel in multiple myeloma

Bristol Myers Squibb (BMY) and bluebird bio (BLUE) announced the FDA approval for idecabtagene vicleucel (ide-cel) for a certain category of adult patients with relapsed or refractory multiple myeloma. The FDA authorization has come a day ahead of the action date.The approval for the chimeric antigen receptor (“CAR”) T cell immunotherapy is now indicated for adults with R/R multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.The treatment which will be marketed under the brand name Abecma includes a Boxed Warning, and a Risk Evaluation and Mitigation Strategy ("REMS") program at certified treatment centers to ensure the appropriate use of Abecma.Abecma will be manufactured at Bristol Myers’ cellular immunotherapy manufacturing facility in Summit, New Jersey. bluebird bio has developed the lentiviral vector, used to engineer the CAR T cells.The FDA approval is supported by the results from the pivotal Phase

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Bristol Myers and Bluebird bio wins FDA approval for ide-cel in multiple myeloma