FDA Accepts Biologics License Application (BLA) for investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Ide-cel for treatment of multiple myeloma

Application is for treatment of adult patients who have received ≥3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The BLA is based on results from Phase II KarMMa study, which met its primary endpoint of overall survival.

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Biospace Inc.