Legend's cilta-cel NDA accepted in China

3 January 2023

USA-based Legend Biotech Corporation (Nasdaq: LEGN) has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).

This submission is based on data from the confirmatory Phase II study CARTIFAN-1 conducted in China, which evaluated the efficacy and safety of cilta-cel in adults with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug.

"Incidence and mortality rates of multiple myeloma have recently increased in China"

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