FDA refuses review of licensing application for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pretreated relapsed and refractory multiple myeloma

The FDA said it will need additional data in order to review the application for this investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for treatment of adults with multiple myeloma who have received ≥ 3prior therapies


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