Astellas Pharma has announced that the European Commission (EC) has granted Marketing Authorisation for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as a perioperative treatment for adults with resectable Muscle-Invasive Bladder Cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

The approval allows the combination to be used as neoadjuvant treatment before surgery and continued as adjuvant therapy after radical cystectomy, establishing the first and only approved perioperative treatment option for this patient population across the European Union.

The decision is based on findings from the Phase 3 EV-303 clinical trial, which demonstrated that perioperative treatment with enfortumab vedotin and pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared with surgery alone in patients who were unable or unwilling to receive cisplatin-based chemotherapy. The combination therapy reduced the risk of tumour recurrence, disease progression or death by 60 percent.

According to the trial results, the safety profile of the combination was consistent with the known profiles of both medicines, with no new safety concerns identified. The most commonly reported treatment-related adverse events included itching, hair loss, diarrhoea, fatigue and anaemia.

Commenting on the approval, Moitreyee Chatterjee-Kishore, Executive Vice President and Head of Oncology Development at Astellas, said the authorisation marks a significant advancement for patients with muscle-invasive bladder cancer who have historically faced limited treatment options when ineligible for cisplatin-based chemotherapy.

Christof Vulsteke, Head of the Integrated Cancer Center Ghent in Belgium and Principal Investigator of the EV-303 study, noted that despite surgery with curative intent, many patients with muscle-invasive bladder cancer experience disease recurrence. He said the study demonstrated clinically meaningful improvements in both event-free and overall survival, supporting the combination as an important new treatment option in Europe.

Patient advocacy groups also welcomed the development. Alex Filicevas, Executive Director of the World Bladder Cancer Patient Coalition, said the approval represents meaningful progress for patients and families who often face uncertainty due to the high risk of cancer recurrence following surgery.

Bladder cancer remains a major healthcare challenge across Europe, with nearly 200,000 new diagnoses each year. Muscle-invasive bladder cancer accounts for up to 30 percent of all bladder cancer cases, and nearly half of these patients are unable to receive cisplatin-containing chemotherapy. Until now, no approved perioperative treatment options existed for this patient group despite the substantial risk of disease recurrence after surgery.

The Padcev-Keytruda combination is already approved in Europe as a first-line treatment for patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. The latest authorization expands its use into earlier-stage disease, bringing the therapy into a potentially curative treatment setting for patients with resectable MIBC.

Astellas stated that it is working closely with regulatory authorities and healthcare assessment bodies across Europe to support patient access to the newly approved treatment. The company has also incorporated the impact of the EC approval into its financial forecast for the fiscal year ending March 31, 2027.