MRK · News · 20260918N

Regulatory Approval Milestones

Merck & Co., Inc. · 2026-09-18 · Importance 47 · Surprise 60 · In source text

Merck received a positive opinion from the European Medicines Agency’s CHMP recommending KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for perioperative treatment of adults with resectable muscle-invasive bladder cancer. The recommendation covers neoadjuvant treatment before radical cystectomy followed by adjuvant treatment, expanding the combination’s potential use in European oncology markets. The Phase 3 KEYNOTE-B15 study showed significant reductions in event-free-survival events and risk of death versus traditional chemotherapy, with a European Commission marketing-authorization decision expected by the fourth quarter of 2026.

Key facts

• Merck received a favorable recommendation from a European regulatory committee for Keytruda in combination with Padcev for treating adults with resectable muscle-invasive bladder cancer. source
• The recommendation is based on positive results from the Phase 3 KEYNOTE-B15 study showing a significant reduction in event-free survival events and risk of death compared to traditional chemotherapy. source
• Merck's filing notes the CHMP recommendation and that it builds on prior regulatory approvals in Europe and the U.S. for related bladder cancer indications. source

Impact estimates