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Legend says China accepts ciltacabtagene New Drug Application
The Fly

Legend says China accepts ciltacabtagene New Drug Application

Legend Biotech announced that China’s National Medical Products Administration has formally accepted its New Drug Application for ciltacabtagene autoleucel. 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, the company said in a statement. Ying Huang, Chief Executive Officer of Legend, said: "Meeting medical needs and serving patients around the world has always been the goal of Legend Biotech’s innovative research and development. Cilta-cel has been approved for marketing in the United States and Japan and has received conditional marketing authorization in Europe. We look forward to the possibility of providing a new treatment option for appropriate patients with relapsed and refractory multiple myeloma in China."

Published first on TheFly

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