EMA validates Type II variation application for Padcev-Keytruda combination

Pfizer (PFE) and Astellas Pharma (ALPMY) announced that on January 26 the European Medicines Agency validated for review a Type II variation application for PADCEV with KEYTRUDA as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer. If approved, PADCEV with KEYTRUDA 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. Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually.1 It is estimated that approximately 200,000 people in Europe are diagnosed with bladder cancer each year.