Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer

Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…