European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer

Astellas

26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival.

Astellas Pharma  and Pfizer today announced that on 26 January 2024 the EMA validated for review a type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.

Read Astellas press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier