Astellas PADCEV and Keytruda Gain Positive CHMP Opinion

Tokyo, Japan, September 17, 2026

Astellas Advances PADCEV and Keytruda in MIBC

The CHMP recommendation expands the European regulatory pathway for PADCEV plus KEYTRUDA into the perioperative treatment of eligible patients with resectable MIBC. Under the recommended indication, patients receive the combination as neoadjuvant treatment before radical cystectomy and continue treatment afterward as adjuvant therapy. The approach is intended for adults with resectable MIBC who cannot receive cisplatin-based chemotherapy. Muscle-invasive bladder cancer occurs when bladder cancer has invaded the muscle layer of the bladder wall and can carry a substantial risk of recurrence or progression even when surgery is performed with curative intent.

The European Medicines Agency describes the PADCEV and pembrolizumab combination as a perioperative treatment approach, incorporating systemic therapy both before and after bladder removal. The CHMP opinion represents a regulatory recommendation rather than the final European Commission decision. Following a positive CHMP opinion, the European Commission makes the legally binding decision on changes to the marketing authorization. The EMA states that the detailed recommendations will be reflected in the updated product information after the Commission decision.

Phase 3 EV-304 Trial Shows Survival Benefits

The positive opinion is supported by results from the Phase 3 EV-304 trial, which evaluated perioperative PADCEV plus KEYTRUDA in patients with resectable MIBC who were ineligible for cisplatin-based chemotherapy or otherwise met the study criteria. According to Astellas, the trial demonstrated a 47% reduction in the risk of disease recurrence, progression, or death and a 35% reduction in the risk of death compared with the control group. The trial therefore assessed two clinically important outcomes: event-free survival and overall survival. Event-free survival captures events such as recurrence or progression, while overall survival measures time to death from any cause. The findings provide the clinical basis for the regulatory consideration of the PADCEV and KEYTRUDA combination in the perioperative setting.

Earlier European regulatory action had already established the combination for cisplatin-ineligible patients with resectable MIBC. The European Commission granted marketing authorization in June 2026 for PADCEV plus KEYTRUDA as neoadjuvant treatment followed by adjuvant treatment after radical cystectomy. That approval was based on Phase 3 EV-303 results, which showed significant improvements in event-free and overall survival compared with surgery alone.

Astellas Expands Bladder Cancer Treatment Strategy

The latest regulatory development further supports the role of enfortumab vedotin and pembrolizumab across different stages of urothelial cancer. PADCEV is an antibody-drug conjugate, while KEYTRUDA is an immune checkpoint inhibitor targeting the PD-1 pathway. Their combination represents an approach that pairs targeted delivery of a cytotoxic payload with immune-based cancer treatment. The EMA currently recognizes PADCEV with pembrolizumab for certain adults with unresectable or metastatic urothelial carcinoma, while PADCEV also has indications as monotherapy in previously treated advanced or metastatic disease. The MIBC indication adds a treatment setting focused on patients whose disease remains potentially removable by surgery.

For Astellas and its partner Merck, the positive CHMP opinion represents another regulatory milestone for the PADCEV plus KEYTRUDA combination in bladder cancer. If the European Commission confirms the recommendation, the updated authorization would further establish the combination’s use around surgery for eligible patients with resectable MIBC. The development also highlights the continuing evolution of perioperative bladder cancer treatment, where systemic therapy is increasingly being evaluated before and after surgery to reduce recurrence and improve long-term outcomes. For patients who cannot receive cisplatin-based chemotherapy, regulatory developments involving alternative systemic treatment strategies remain an important area of clinical research and drug development.

Source: Astellas press release