Legend Biotech Announces Acceptance of Its New Drug Application (NDA) for Ciltacabtagene Autoleucel (Cilta-Cel) in China

Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, 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 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.

Saijuan Chen, M.D., hematologist and molecular geneticist, Academician of the Chinese Academy of Engineering, and principal investigator of the CARTIFAN-1 clinical trial, said: “Incidence and mortality rates of multiple myeloma have recently increased in China, and the disease remains incurable. As a result, there is a huge unmet medical need for new treatment options. The data from the CARTIFAN-1 study showed that cilta-cel provided deep and durable responses in patients with relapsed or refractory multiple myeloma. We hope this drug becomes available to eligible patients as soon as possible.”

Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech, 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.”