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Janssen announces extension of FDA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel for multiple myeloma

Read time: 1 mins
Published:3rd Nov 2021
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA).

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.

Condition: Multiple Myeloma
Type: drug

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