26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy.

Astellas Pharma today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of Padcev (enfortumab vedotin, an antibody-drug conjugate) in combination with Keytruda (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.

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