Merck’s blockbuster cancer drug Keytruda, combined with Padcev, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), paving the way for a potential EU approval in adults with resectable muscle-invasive bladder cancer.

 

The recommendation covers the use of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin-ejfv) before surgery and continued after radical cystectomy as adjuvant treatment.

 

The European Commission will now review the recommendation, with a final decision expected in the fourth quarter of 2026.

 

If approved, the combination would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with muscle-invasive bladder cancer regardless of whether they are eligible for cisplatin-based chemotherapy.

 

“Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility, and up to half may be unable to receive cisplatin-based chemotherapy,” said Marjorie Green, senior vice president, oncology, global clinical development, Merck Research Laboratories. 

 

“If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for people with muscle-invasive bladder cancer regardless of cisplatin eligibility, expanding on the previously approved indication.”

 

The CHMP opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas.

 

Among patients with MIBC who were eligible for cisplatin, the Keytruda-Padcev regimen significantly improved event-free survival compared with neoadjuvant chemotherapy followed by surgery.

 

The combination reduced the risk of an event — defined as disease progression, recurrence or death — by 47%. The hazard ratio was 0.53, with a 95% confidence interval of 0.41 to 0.70 and p<0.0001.

 

Overall survival also improved, with the combination reducing the risk of death by 35% compared with chemotherapy and surgery. The hazard ratio was 0.65, with a 95% confidence interval of 0.48 to 0.89 and p=0.0029.

 

The trial also showed a substantial improvement in pathologic complete response. The pCR rate was 55.8% with Keytruda plus Padcev, compared with 32.5% with neoadjuvant chemotherapy.

 

The latest recommendation builds on a regulatory expansion already secured in Europe.

 

In June 2026, the European Commission approved Keytruda, including the subcutaneous formulation KEYTRUDA SC, in combination with Padcev for neoadjuvant and subsequent adjuvant treatment of adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy. That approval was based on the Phase 3 KEYNOTE-905 trial.

 

The latest CHMP recommendation is based on KEYNOTE-B15 and addresses patients eligible for cisplatin-based chemotherapy, potentially extending the combination across the broader MIBC population.

 

The combination has also moved ahead in the United States. In July 2026, the U.S. Food and Drug Administration approved Keytruda plus Padcev as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with MIBC, based on KEYNOTE-B15.

 

Bladder cancer is the eighth most common cancer worldwide, with more than 635,000 cases diagnosed each year, according to Merck. In Europe, about 224,700 cases and more than 70,300 deaths were estimated in 2022.

 

Merck says up to half of patients with MIBC may be unable to receive cisplatin, leaving them with fewer treatment options.

 

The KEYNOTE-B15 findings therefore target a key treatment gap: improving outcomes before and after surgery while providing a regimen that can potentially be used regardless of cisplatin eligibility.

 

The proposed EU indication remains subject to the European Commission’s final decision.