Japanese pharmaceutical company Astellas Pharma Inc (TSE:4503) announced on Wednesday that China's National Medical Products Administration (NMPA) has approved PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer.

This approval was based on the Phase 3 EV-302 trial, which demonstrated significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.

The treatment combination offers a new therapeutic option for patients with advanced bladder cancer in China. Bladder cancer is a significant public health concern in the country, with more than 92,000 new cases diagnosed in 2022.