BRIEF—EMA validates Padcev with Keytruda Type II variation application

US pharma giant Pfizer and Japan’s Astellas Pharma announced that on January 26 the European Medicines Agency (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 (la/mUC).

If approved, Padcev with Keytruda (Merck & Co’s blockbuster cancer drug) has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.