Posted by Michael Wonder on 31 Mar 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (Ide-cel, bb2121) to FDA
31 March 2020 - 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.
Bristol Myers Squibb and bluebird bio today announced the submission of their biologics license application to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen-directed chimeric antigen receptor 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.
