FDA Refusal to File letter for Idecabtagene Vicleucel (ide-cel, bb2121) for the treatment of myeloma patients
Bristol Myers Squibb (BMS) and bluebird bio, Inc have announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory myeloma, which was submitted in March 2020.