China approves Padcev for the treatment of locally advanced or metastatic urothelial cancer

TOKYO (dpa-AFX) – Astellas Pharma Inc. (ALPMY, ALPMY) announced that the Center for Drug Evaluation of the China 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-based 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 Chinese EV-203 studies, which showed that enfortumab vedotin significantly improved overall survival and objective response rate in patients after prior treatment with platinum-based chemotherapy and PD-1/L1 inhibitors.

Astellas said it has already factored the impact of the approval of enfortumab vedotin in China into its financial guidance for the current fiscal year ending March 31, 2025.

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