J&J, Legend Biotech Launch Rolling Submission for CAR-T Therapy for Multiple Myeloma

Johnson & Johnson (J&J) and Legend Biotech said they have begun submitting documents on a rolling basis to the FDA for a Biologics License Application for their investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel), meant for adults suffering from relapsed or refractory multiple myeloma.

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

The FDA granted cilta-cel Breakthrough Therapy and Orphan Drug designations in 2019, and the therapy received a PRIME Priority Medicines designation from the European Commission (EC) that same year and an Orphan Drug designation from the EC in February 2020. Cilta-cel also won a Breakthrough Therapy designation in China in August.