Astellas & Pfizer's SBLA For Enfortumab Vedotin With Keytruda Gets Approval In China

(RTTNews) - Astellas Pharma Inc. (ALPMY) announced that China's National Medical Products Administration or NMPA has accepted the supplemental Biologics License Application or sBLA for enfortumab vedotin with Keytruda as a combination therapy for the treatment of patients with advanced bladder cancer.

The sBLA, filed along with Pfizer, was based on data from Phase 3 EV-302 trial, which found that the combination therapy was more effective in patients than platinum-containing chemotherapy.

The company further stated that the enfortumab vedotin in combination with pembrolizumab therapy is also being reviewed by Europe's Committee for Medicinal Products for Human Use, Japan's Ministry of Health, Labour and Welfare, and the U.S.'s Food and Drug Administration.

Currently, Astellas's stock is trading at $10.76, down 1.69 percent on the Other OTC.