Astellas Pharma Inc. (ALPMY) announced the approval of Padcev (enfortumab vedotin) by the Center for Drug Evaluation of China's National Medical Products Administration. This approval pertains to the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously undergone treatment with platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors.
This decision is grounded in the results from the global EV-301 and China EV-203 trials. In these studies, enfortumab vedotin demonstrated a significant improvement in overall survival and objective response rate in patients who had received prior treatments with platinum-based chemotherapy and PD-1/L1 inhibitors.
Astellas also confirmed that the financial impact of this approval has already been factored into their forecast for the fiscal year ending March 31, 2025.
