Merck gets EU review for KEYTRUDA bladder cancer use

• Merck (NYSE:MRK) received a positive CHMP opinion recommending KEYTRUDA plus Padcev for resectable muscle-invasive bladder cancer.
• The recommendation follows Phase 3 KEYNOTE-B15 results showing improvements in event-free survival, overall survival and pathologic complete response.
• The European Commission is expected to make a final marketing authorization decision by the fourth quarter of 2026.

Merck (NYSE:MRK) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending KEYTRUDA (pembrolizumab) combined with Padcev (enfortumab vedotin-ejfv) for adults with resectable muscle-invasive bladder cancer.

The recommendation covers use before surgery and continued treatment after radical cystectomy, following results from the Phase 3 KEYNOTE-B15 trial, which showed improvements in event-free survival, overall survival and pathologic complete response rates.

“Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility,” said Dr. Marjorie Green, senior vice president of oncology, global clinical development, Merck Research Laboratories.

In KEYNOTE-B15, KEYTRUDA plus Padcev reduced the risk of event-free survival events by 47% compared with neoadjuvant chemotherapy and surgery, while overall survival results showed a 35% reduction in the risk of death and pathologic complete response improved to 55.8% from 32.5%.

Merck develops medicines across oncology, vaccines and other therapeutic areas, with KEYTRUDA being an anti-PD-1 therapy used in multiple cancer indications.

The European Commission will review the CHMP recommendation for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected in the fourth quarter of 2026.