Global Finance News
19 Sep 2026, 10:57
Merck Wins Positive EU CHMP Opinion for KEYTRUDA-Padcev Bladder Cancer Regimen
Merck said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer.
The recommendation covers use before surgery as neoadjuvant therapy and continued treatment after radical cystectomy as adjuvant therapy. A European Commission decision is expected by the fourth quarter of 2026. If approved, the combination would become the first PD-1 inhibitor plus antibody-drug conjugate regimen in the EU for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility.
The CHMP opinion is based on the Phase 3 KEYNOTE-B15 trial. In cisplatin-eligible patients, KEYTRUDA plus Padcev reduced the risk of an event-free survival event by 47% versus neoadjuvant chemotherapy and surgery. The regimen also reduced the risk of death by 35% and produced a pathologic complete response rate of 55.8%, compared with 32.5% in the control group.
The combination is already approved in the U.S. for muscle-invasive bladder cancer regardless of cisplatin eligibility, while the EU previously approved it for cisplatin-ineligible patients.
The latest recommendation could broaden Merck’s position in earlier-stage bladder cancer and further expand KEYTRUDA’s role beyond advanced disease.
Merck said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer.
The recommendation covers use before surgery as neoadjuvant therapy and continued treatment after radical cystectomy as adjuvant therapy. A European Commission decision is expected by the fourth quarter of 2026. If approved, the combination would become the first PD-1 inhibitor plus antibody-drug conjugate regimen in the EU for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility.
The CHMP opinion is based on the Phase 3 KEYNOTE-B15 trial. In cisplatin-eligible patients, KEYTRUDA plus Padcev reduced the risk of an event-free survival event by 47% versus neoadjuvant chemotherapy and surgery. The regimen also reduced the risk of death by 35% and produced a pathologic complete response rate of 55.8%, compared with 32.5% in the control group.
The combination is already approved in the U.S. for muscle-invasive bladder cancer regardless of cisplatin eligibility, while the EU previously approved it for cisplatin-ineligible patients.
The latest recommendation could broaden Merck’s position in earlier-stage bladder cancer and further expand KEYTRUDA’s role beyond advanced disease.
