Legend Biotech announces acceptance of its new drug application for ciltacabtagene autoleucel in China

Legend Biotech

2 January 2023 - Legend Biotech announced today that China’s NMPA has formally accepted its new drug application for ciltacabtagene autoleucel (cilta-cel).

This submission is based on data from the confirmatory Phase 2 clinical study CARTIFAN-1 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.

Read Legend Biotech press release

Michael Wonder

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Michael Wonder