Posted by Michael Wonder on 13 May 2020
Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma
Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. FDA regarding the biologics license application for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.
Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control module of the application 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.
