Bristol Myers Squibb and bluebird bio have resubmitted their Biologics License Application (BLA) to the U.S. FDA for an investigational CAR-T cell therapy designed to treat patients with relapsed and refractory multiple myeloma.
The drugmakers originally submitted the BLA for idecabtagene vicleucel in March 2020 but received a refusal to file letter from the FDA two months later, with the agency noting concerns about the manufacturing process of the therapy. According to the companies, the updated submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests.
BMS picked up the therapy as part of its $74 billion takeover of Celgene. Ide-cel is one of three treatments with a contingent value right for Celgene investors, who will receive an additional $9 a share if the therapies receive an approval before certain dates. BMS needs to win approval for ide-cel by the end of March 2021 to meet the deadline.
