Posted by Michael Wonder on 06 Aug 2020
The China Center for Drug Evaluation, National Medical Products Administration has recommended breakthrough therapy designation for ciltacabtagene autoleucel, an investigational BCMA CAR-T Cell therapy
5 August 2020 - Legend Biotech announced today that the China Center for Drug Evaluation, National Medical Products Administration has recommended breakthrough therapy designation for ciltacabtagene autoleucel, an investigational B-cell maturation antigen targeted chimeric antigen receptor T-cell therapy being studied for the treatment of adults with relapsed or refractory multiple myeloma.
The breakthrough therapy designation for ciltacabtagene autoleucel is based on the ongoing Phase 2 CARTIFAN-1 study being conducted in China, the ongoing Phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel (JNJ-4528) being conducted in the US and Japan and the Phase 1, first-in-human LEGEND-2 study conducted in China.
Ciltacabtagene autoleucel refers to both LCAR-B38M CAR-T cells and JNJ-4528. LCAR-B38M CAR-T cell identifies the investigational product being studied in China and JNJ-4528 identifies the investigational product being studied outside of China, both of which are representative of the same CAR-T cell therapy.
