Merck announced on October 21, 2026, that the European Commission (EC) approved KEYTRUDA in combination with Astellas and Pfizer’s Padcev for adults with resectable muscle-invasive bladder cancer (MIBC).
The approval covers perioperative treatment: patients receive the combination before surgery (neoadjuvant) and continue treatment after surgery (adjuvant).
It is the first and only European Union approval of a PD-1 inhibitor combined with an antibody-drug conjugate (ADC) for this patient group, regardless of patients’ eligibility for cisplatin-based chemotherapy.
The EC based its decision on positive results from the KEYNOTE-B15 clinical trial, which demonstrated meaningful advancements for patients with this cancer.