Merck & Co., Inc. (NYSE:MRK) secured a favorable recommendation from a European regulatory committee for its cancer therapy Keytruda in combination with Padcev to treat adults facing resectable muscle-invasive bladder cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use backed the perioperative combination, which includes the subcutaneous version KEYTRUDA SC, as a neoadjuvant and adjuvant treatment for patients undergoing radical cystectomy.

Positive Clinical Trial Results Support Recommendation

The positive stance relies on data from the Phase 3 KEYNOTE-B15 study, conducted alongside Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (OTC:ALPMF) (OTC:ALPMY).

The trial demonstrated that perioperative KEYTRUDA plus Padcev cut the risk of event-free survival events, such as disease recurrence, progression, or death, by 47% compared to traditional gemcitabine and cisplatin chemotherapy plus surgery in cisplatin-eligible patients.

Furthermore, the combination reduced the risk of death by 35% in these patients while achieving a 55.8% pathologic complete response rate versus 32.5% for standard chemotherapy.

The European Commission plans to evaluate the recommendation, with a final decision for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway expected by the fourth quarter of 2026.

Regulatory Approvals Expand Global Bladder Cancer Treatment Access

This recommendation follows previous regulatory milestones achieved earlier in the year.

In June 2026, the European Commission authorized the regimen for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer, supported by findings from the Phase 3 KEYNOTE-905 trial.

Additionally, the U.S. Food and Drug Administration cleared KEYTRUDA alongside Padcev in July 2026 for adult patients based on the KEYNOTE-B15 study.

That decision made it the first and only PD-1 inhibitor and antibody-drug conjugate combination approved in the United States for muscle-invasive bladder cancer regardless of cisplatin eligibility.

MRK Price Action: Merck shares were down 0.66% to $146.18 at the time of publication on Friday, according to Benzinga Pro data.

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