FX.co ★ Astellas & Pfizer's SBLA For Enfortumab Vedotin With Keytruda Gets Approval In China

Astellas Pharma Inc. has announced that the National Medical Products Administration in China (NMPA) has recognized the supplementary Biologics License Application (sBLA) for a merging of enfortumab vedotin and Keytruda. This combination therapy intends to aid the treatment of patients suffering from advanced bladder cancer.

The sBLA was jointly submitted alongside Pfizer, capitalizing on findings from the Phase 3 EV-302 trial. This research indicated that the combined therapy demonstrated more effectiveness in patients compared to those treated with platinum-containing chemotherapy.

Additionally, Astellas reported that the pairing of enfortumab vedotin and pembrolizumab is currently under consideration by Europe's Committee for Medicinal Products for Human Use, the Ministry of Health, Labour and Welfare in Japan, as well as the Food and Drug Administration in the USA.

At present, trading shares of Astellas stand at a price of $10.76, reflecting a moderate decrease at 1.69 percent on the Other OTC.