Astellas : China Approves Padcev For Treatment Of Locally Advanced Or Metastatic Urothelial Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the Center for Drug Evaluation of China's National Medical Products Administration has approved Padcev (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.

The approval is based on the global EV-301 and China EV-203 trials, where enfortumab vedotin significantly improved overall survival and objective response rate respectively in patients following prior treatment with platinum-based chemotherapy and PD-1/L1 inhibitors.

Astellas said it has already reflected the impact from the approval for enfortumab vedotin in China in its financial forecast for the current fiscal year ending March 31, 2025.

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