Bristol Myers Squibb gets EMA validation for Idecabtagene Vicleucel, CC-486
Princeton: Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each application confirms the respective submissions are complete and begins the EMA's centralized review process.
The MAA for ide-cel, the company's investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy co-developed with bluebird bio, Inc., is for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel was granted Accelerated Assessment status by the EMA in March, reducing the maximum timeframe for review of the application to 150 days.
"Europe has one of the highest incidence rates of multiple myeloma, and patients who have relapsed and are refractory to standard treatment regimens are in need of treatment options to improve outcomes," said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb. "We will continue to work with the EMA to bring ide-cel to patients in the European Union who are battling this aggressive blood cancer."
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