Posted by Michael Wonder on 27 May 2021
U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma
26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application submitted by Janssen Biotech for ciltacabtagene autoleucel, an investigational B-cell maturation antigen directed chimeric antigen receptor T cell therapy.
The Prescription Drug User Fee Act target action date has been set for 29 November 2021.
