Astellas：PADCEV®Enfortumab vedotinreceived marketing approval
On June 24, Astellas announced that the European Commission has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant therapy (pre-surgical treatment), followed by adjuvant therapy after radical cystectomy, for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. According to an Astellas press release, this is the first and only approved perioperative treatment regimen in the EU for this patient population.
Enfortumab vedotin is the world’s first approved Nectin-4 ADC, previously approved in multiple countries and regions including the United States, the European Union, Japan, and China for the treatment of bladder cancer, with global sales of approximately $3.4 billion in 2025 (YOY +25.37%). In Europe, the enfortumab vedotin plus pembrolizumab combination had previously been approved as a first-line regimen for patients with unresectable or metastatic urothelial carcinoma who are eligible for platinum-containing chemotherapy.
This new indication approval is based on results from the EV-303 Phase III clinical trial (KEYNOTE-905). The trial results were recently published in The New England Journal of Medicine. EV-303 is an open-label, randomized, three-arm controlled Phase III study enrolling patients with MIBC who were ineligible for or refused cisplatin-based chemotherapy. The trial consisted of three arms: pembrolizumab neoadjuvant and adjuvant therapy (Arm A), surgery alone (Arm B), and enfortumab vedotin plus pembrolizumab neoadjuvant and adjuvant therapy (Arm C).
EV-303 trial data demonstrated that for patients with MIBC ineligible for or who refused cisplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab as a perioperative regimen significantly improved event-free survival (EFS) and overall survival (OS) compared with surgery alone. The combination therapy reduced the risk of recurrence, progression, or death by 60% (hazard ratio [HR] 0.40; 95% confidence interval [CI] 0.28–0.57; p<0.0001), and reduced the risk of death by 50% (HR 0.50; 95% CI: 0.33–0.74; p=0.0002). In terms of safety, the combination was consistent with the known safety profiles of the individual agents, with no new safety signals observed. The most common adverse events (≥30%) in the combination arm included pruritus, alopecia, diarrhea, fatigue, and anemia.
Bladder cancer remains a significant health burden in Europe, with approximately 200,000 new cases diagnosed annually. Muscle-invasive bladder cancer accounts for up to 30% of all bladder cancer cases. Up to half of MIBC patients are ineligible for cisplatin-based chemotherapy. Despite the high risk of disease recurrence after surgery, no approved perioperative treatment option had previously been available for these patients. The approval of enfortumab vedotin plus pembrolizumab provides a new treatment option for this patient population.
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