Janssen in rolling submission for BCMA Car-T therapy in multiple myeloma

 

• Janssen Pharmaceutical, a unit of Johnson & Johnson (JNJ -0.9%) has started rolling submission of its marketing application to the FDA seeking approval for ciltacabtagene autoleucel (cilta-cel), for the treatment of adults with relapsed and/or refractory multiple myeloma.
• Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy.
• The submission is based on results from Phase 1b/2 CARTITUDE-1 study, that demonstrated overall response rate of 97%, with 67% of patients achieving a stringent complete response, but 14 deaths were reported during the study, including six due to adverse events related to treatment.
• The event triggered a milestone payment of $75M to its partner Legend Biotech (LEGN -2.0%).
• https://seekingalpha.com/news/3646305-janssen-begins-rolling-submission-of-marketing-application-for-bcma-car-t-therapy-in-multiple