On September 18, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer (MIBC). This recommendation, which also includes KEYTRUDA SC [known as KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected by the fourth quarter of 2026.
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"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 Dr. 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 recommendation is based on results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events (defined as disease progression, recurrence or death) by 47% (HR=0.53 [95% CI, 0.41-0.70]; p<0.0001; 87/405 [21%] versus 146/403 [36%]) in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery. KEYTRUDA plus Padcev also demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 35% (HR=0.65 [95% CI, 0.48-0.89]; p=0.0029; 69/405 [17%] versus 99/403 [25%]) in these patients when compared to neoadjuvant chemotherapy and surgery. The trial showed KEYTRUDA plus Padcev demonstrated a statistically significant improvement in pathologic complete response (pCR) rate compared to neoadjuvant chemotherapy (55.8% [95% CI: 50.8, 60.7] versus 32.5% [95% CI: 28.0, 37.3]; p<0.0001).
In June 2026, the EC approved KEYTRUDA, which also includes KEYTRUDA SC, in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy based on the Phase 3 KEYNOTE-905 trial.
In July 2026, KEYTRUDA in combination with Padcev was approved by the U.S. Food and Drug Administration (FDA) as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with MIBC based on the Phase 3 KEYNOTE-B15 trial. This also represented the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimen approved in the U.S. for adults with MIBC regardless of cisplatin eligibility.
About bladder cancer
Bladder cancer is the eighth most common cancer worldwide, diagnosed in more than 635,000 patients each year globally. In Europe, it is estimated there were approximately 224,700 patients diagnosed with bladder cancer and more than 70,300 deaths from the disease in 2022. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence. Additionally, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.
(Press release, Merck & Co, SEP 18, 2026, View Source [SID1234670949])