The European Commission approved Pfizer and Merck’s combination therapy, Keytruda and Padcev, for a specific bladder cancer. This marks the first PD-1 inhibitor and antibody-drug conjugate (ADC) combination approved for this indication in the EU.
The approval targets adult patients with resectable muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy. Treatment involves using the combination both before surgery as a neoadjuvant and after surgery as an adjuvant.
Data from the Phase 3 KEYNOTE-905 trial supported the decision. The study demonstrated significant improvements in event-free survival and overall survival compared to surgery alone.
This milestone strengthens Pfizer’s oncology portfolio following its acquisition of Seagen. Seagen co-developed Padcev alongside Astellas.