Refusal to File letter for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma. BMS + bluebird bio

Bristol Myers Squibb and bluebird bio, Inc. announced that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.</p.

Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July 2020.