Seagen, Astellas says China’s NMPA accepts BLA for enfortumab vedtoin

Astellas Pharma Inc. (ALPMY) and Seagen Inc. (SGEN) announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted the Biologics License Application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. "In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "Enfortumab vedotin has become a second- and third-line treatment option for many patients around the world with previously treated locally advanced or metastatic urothelial cancer, and an approval in China may bring this therapy to those patients."