Merck wins EU approval for Keytruda-Padcev combination in muscle-invasive bladder cancer
MRK•The European Commission approved Merck’s Keytruda-Padcev combination before and after surgery for adults with resectable muscle-invasive bladder cancer. The authorization covers 27 EU member states, Iceland, Liechtenstein and Norway.
1. EU authorization
The European Commission approved Keytruda with Padcev as treatment before and following surgery for adults with resectable muscle-invasive bladder cancer. The regimen is the EU’s first PD-1 inhibitor–antibody-drug conjugate combination for this population, regardless of eligibility for cisplatin chemotherapy.
2. Trial and availability
Previously reported Phase 3 KEYNOTE-B15 results showed improved survival and reduced disease progression or recurrence versus chemotherapy with surgery in cisplatin-eligible patients. Commercial availability depends partly on national reimbursement procedures. U.S. regulators cleared the regimen for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility in July 2026.
