European Commission Approves Astellas' PADCEV TM (enfortumab vedotin) in ...
European Commission grants Marketing Authorization for PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer eligible for platinum-containing chemotherapy. Approval based on Phase 3 EV-302 trial results showing nearly doubled median overall survival and significantly extended progression-free survival compared to platinum-containing chemotherapy.
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Enfortumab vedotin + pembrolizumab could replace platinum-based chemo for unresectable/metastatic urothelial cancer, per CHMP's positive opinion based on Phase 3 EV-302 trial results showing nearly double median overall survival.
European Commission approves Astellas' PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of advanced urothelial cancer, based on Phase 3 EV-302 trial results showing improved overall survival and progression-free survival compared to platinum-containing chemotherapy.
European Commission grants Marketing Authorization for PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer eligible for platinum-containing chemotherapy. Approval based on Phase 3 EV-302 trial results showing nearly doubled median overall survival and significantly extended progression-free survival compared to platinum-containing chemotherapy.