Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the U.S. FDA for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen directed chimeric antigen receptor T-cell therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.
The FDA previously granted breakthrough therapy designation for cilta-cel and has agreed to a rolling review of the biologics license application in which completed portions of the application will be submitted and reviewed on an ongoing basis.
