Bristol Myers Squibb and bluebird bio re-file BLA for ide-cel

US pharma major Bristol-Myers Squibb (NYSE: BMY) and partner bluebird bio (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the US Food and Drug Administration for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma.

The agency previously issued a surprise ‘refuse to file’ letter relating to the original filing in March this year. This re-submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020.

The submission is based on results from the pivotal Phase II KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.1