BMS and bluebird bio Submit Biologics License Application to FDA for CAR T Therapy
Bristol Myers Squibb and bluebird bio announced their submission for a Biologics License Application (BLA) to the FDA for the approval of the bb2121 CAR T therapy, now called ide-cel. The CAR T therapy works on a target called B-cell maturation antigen (BCMA), a new approach in multiple myeloma. The approval is requested for highly relapsed and refractory multiple myeloma.
The submission is based on results from the pivotal Phase 2 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.
For patients who have relapsed after the core myeloma drug classes (IMiDs, proteasome inhibitors and monoclonal antibodies), this is a welcome option. Once a patient has hit this stage, they have fewer options, worse outcomes and shorter overall survival.
The application satisfies a resubmission request from the FDA to provide more detail about the manufacturing process. The product is also going through the European Medicines Agency approval process.
We are hopeful the FDA approval can come before the end of the year to provide a new type of immunotherapy choice to multiple myeloma patients. new CAR T therapy provides an excellent immunotherapy option for highly relapsed patients.