Merck Wins EU Approval for Keytruda-Padcev Combination in Muscle-Invasive Bladder Cancer

• Merck secured European Commission approval for Keytruda with Padcev as treatment before and following surgery for adults with resectable muscle-invasive bladder cancer.
• The regimen becomes the EU’s first PD-1 inhibitor–antibody-drug conjugate combination for this population regardless of eligibility for cisplatin chemotherapy.
• Previously reported Phase 3 KEYNOTE-B15 results showed improved survival and reduced disease progression or recurrence versus chemotherapy with surgery in cisplatin-eligible patients.
• The authorization covers all 27 EU member states, Iceland, Liechtenstein and Norway; 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.

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