Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma.
Bristol Myers Squibb and bluebird bio today announced that the U.S. FDA has accepted for priority review their biologics license application for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen 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 FDA has set a Prescription Drug User Fee Act goal date of 27 March 2021.
