PADCEVTM (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Patients with Resectable Muscle-Invasive Bladder Cancer who are Ineligible for Cisplatin-Based Chemotherapy
May 22, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Astellas Pharma, CHMP, EMA, MSD, oncology, resectable muscle-invasive bladder cancer
Positive opinion is based on data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death compared to surgery alone
22 May 2026 — Tokyo, Japan — Astellas Pharma In today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of PADCEVTM (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the European Union (EU).
Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas, “Patients with muscle-invasive bladder cancer are at high risk of progression to metastatic disease, and those ineligible for cisplatin have historically had fewer treatment options. The EV-303 results demonstrate that enfortumab vedotin in combination with pembrolizumab can address this gap, and the CHMP’s positive opinion is an important step toward making the combination available to patients who need it.”
The positive CHMP opinion is based on results from the Phase 3 EV-303 clinical trial (KEYNOTE-905). In EV-303, neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab was compared with surgery alone in MIBC patients ineligible for or who declined cisplatin-containing chemotherapy. In the Event-Free Survival analysis, the combination demonstrated a 60% reduction in the risk of tumor recurrence, progression, or death (Hazard Ratio (HR) of 0.40, 95% CI, 0.28-0.57; p<0.0001).1 In the Overall Survival analysis, the combination demonstrated a 50% reduction in the risk of death (HR of 0.50 (95% CI: 0.33-0.74; p=0.0002).
The safety profile of enfortumab vedotin in combination with pembrolizumab in EV-303 was consistent with prior experience, and no new safety signals were observed. The most common (≥30%) adverse events related to treatment with the combination were pruritus (itching), alopecia, diarrhea, fatigue, and anemia.
Bladder cancer is the 5th most common cancer in Europe, estimated to affect over 200,000 people a year. MIBC is a type of bladder cancer in which the tumor has grown into or through the muscular wall of the bladder, and represents up to 30% of all bladder cancer cases globally.
The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery. However, up to half of patients with MIBC are not eligible to receive cisplatin and, without access to systemic therapy, face a substantial risk of disease recurrence following surgery.
The positive recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 EU member states as well as Iceland, Liechtenstein and Norway.
Enfortumab vedotin plus pembrolizumab is a first-line treatment option in Europe for patients with locally advanced or metastatic urothelial cancer.8 Approval by the EC would extend the therapeutic use of the combination to an earlier disease setting, where there is a significant unmet need for systemic treatment options.
Astellas has already reflected the impact of the CHMP’s opinion in its financial forecast for the current fiscal year ending March 31, 2027.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women’s health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
About the Pfizer, Astellas and MSD Collaboration
Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen and Astellas’ PADCEV (enfortumab vedotin) and MSD’s KEYTRUDA (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of MSD, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).
