NEW YORK – China's National Medical Products Administration (NMPA) on Monday accepted Legend Biotech's new drug application for the market approval of Carvykti (ciltacabtagene autoleucel) in heavily pretreated relapsed or refractory multiple myeloma.
The NDA for the autologous CAR T-cell therapy includes data from the Phase II CARTIFAN-1 trial conducted in China. The study enrolled relapsed or refractory multiple myeloma patients who had received three or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug. As Legend and collaborators reported in the Journal of Clinical Oncology in October, nearly 90 percent of 48 patients on Carvykti responded and 77 percent achieved a complete response. The 18-month progression-free survival and overall survival rates were 66.8 percent and 78.7 percent, respectively.
"Incidence and mortality rates of multiple myeloma have recently increased in China, and the disease remains incurable," Saijuan Chen, principal investigator of CARTIFAN-1, said in a statement. "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."
Carvykti, which Legend comarkets with Janssen, was approved a year ago in the US for pretreated relapsed or refractory multiple myeloma. In March, European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for Carvykti for the same indication in Europe.
Under Legend and Janssen's 2017 licensing agreement, they share development, production, and commercialization activities for the CAR T-cell therapy. They also have a 50/50 profit-loss sharing agreement for the worldwide market and a 70/30 profit-loss sharing agreement for the greater China market.