Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today 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 2 clinical study CARTIFAN-1 (NCT03758417) conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or refractory multiple myeloma who have received 3 or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug.
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