Posted by Michael Wonder on 09 Dec 2021
Legend Biotech announces submission of new drug application to Japanese regulatory authority for BCMA CAR-T therapy cilta-cel for the treatment of relapsed or refractory multiple myeloma by Janssen
7 December 2021 - Submission based on data from pivotal CARTITUDE-1 trial
Legend Biotech announced today the submission of a new drug application to the Japanese Ministry of Health, Labour and Welfare for ciltacabtagene autoleucel (cilta-cel) by its collaboration partner, Janssen.
Cilta-cel is an investigational B-cell maturation antigen directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
