Janssen announces extension of FDA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel for multiple myeloma
Cilta-cel is a B-cell maturation antigen (BCMA) CAR-T therapy that is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The FDA extended the PDUFA date to allow sufficient time to review information recently submitted by the company pertaining to an updated analytical method following an FDA information request. No additional clinical data have been requested. Janssen is committed to working with the FDA in its ongoing review of the BLA.
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