MSD’s Keytruda-Padcev combo secures EC approval for MIBC

The European Commission has approved the combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) by Merck & Co as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC) in adults with resectable tumors who cannot be treated with cisplatin-based chemotherapy. This is the first combination of a PD-1 inhibitor and an antibody-drug conjugate available across all 27 EU countries as well as Iceland, Liechtenstein, and Norway. The approval is based on results from the KEYNOTE-905/EV-303 trial, which demonstrated that patients receiving the combination achieved statistically significant improvements in event-free survival (60% risk reduction), overall survival (50% risk reduction), and pathologic complete response rate (57.1% versus 8.6% with surgery alone) compared to surgery alone. Both drugs were previously approved for similar indication in the United States in November 2025.