Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to 28 February 2022 for the ciltacabtagene autoleucel (cilta-cel) biologics license application.
Cilta-cel is a B-cell maturation antigen CAR-T therapy that is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma.
