Tokyo, Japan – May 22, 2026
Astellas Pharma Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of PADCEV™ (enfortumab vedotin) in combination with Keytruda® (pembrolizumab) for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. The recommendation supports use of the combination as both neoadjuvant therapy before surgery and adjuvant treatment following radical cystectomy, marking a major advancement in perioperative bladder cancer care within Europe. The positive CHMP opinion was based on strong survival and recurrence reduction data from the pivotal Phase III EV-303/KEYNOTE-905 clinical trial.
The recommendation represents a significant milestone for patients with muscle-invasive bladder cancer who are unable to receive standard cisplatin-based chemotherapy due to underlying health conditions or treatment intolerance. Experts note that these patients historically faced limited treatment options and elevated risks of recurrence, disease progression, and mortality following surgery. The European Commission is expected to review the CHMP recommendation in the coming months for final regulatory approval across European Union member states.
Phase III EV-303 Trial Shows Major Survival Benefits
The positive regulatory opinion was supported by findings from the global Phase III EV-303/KEYNOTE-905 study, which evaluated neoadjuvant and adjuvant PADCEV combined with Keytruda compared with surgery alone in patients with muscle-invasive bladder cancer who were either ineligible for or declined cisplatin-containing chemotherapy. According to trial results, the combination therapy achieved a remarkable 60% reduction in the risk of tumor recurrence, progression, or death compared with surgery alone. The study additionally demonstrated a 50% reduction in the risk of death, reinforcing the combination’s significant survival advantage in this high-risk patient population.
Researchers emphasized that these outcomes represent one of the most important recent advancements in perioperative bladder cancer treatment. Muscle-invasive bladder cancer remains one of the most aggressive forms of urothelial carcinoma and carries a substantial risk of progression to metastatic disease even after surgery. Approximately half of patients with MIBC are considered ineligible for cisplatin-based chemotherapy, leaving many patients without access to systemic therapies prior to this latest development.
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The safety profile observed in the EV-303 trial remained generally consistent with previously reported studies involving PADCEV and Keytruda. The most commonly reported treatment-related adverse events included itching, hair loss, diarrhea, fatigue, and anemia. Importantly, investigators noted that no new safety signals emerged during the study period.
PADCEV Strengthens Role of ADCs in Precision Oncology
PADCEV is a first-in-class antibody-drug conjugate (ADC) targeting Nectin-4, a protein highly expressed on bladder cancer cells. The therapy delivers a potent cytotoxic agent directly into cancer cells following targeted binding, allowing selective destruction of malignant tissue while limiting systemic exposure. Oncology experts believe ADC technologies are rapidly transforming cancer treatment by combining the targeting precision of biologics with the potency of chemotherapy.
The combination with Keytruda, an immune checkpoint inhibitor targeting PD-1, further enhances anti-tumor activity through complementary mechanisms involving immune system activation and targeted cancer cell destruction. Analysts believe the success of PADCEV plus Keytruda highlights the growing importance of combination immunotherapy and ADC-based strategies in precision oncology and personalized cancer treatment.
Bladder cancer remains the fifth most common cancer in Europe, affecting more than 200,000 people annually. Muscle-invasive disease accounts for approximately 30% of all bladder cancer cases globally and is associated with particularly aggressive progression patterns and high recurrence risk. Healthcare providers continue seeking improved perioperative treatment approaches capable of reducing relapse rates and extending long-term survival outcomes for affected patients.
Astellas Expands Oncology Leadership in Urothelial Cancer
The positive CHMP recommendation further strengthens Astellas’ growing oncology portfolio and expands the global role of PADCEV within bladder cancer management. PADCEV plus Keytruda is already approved in multiple international markets for locally advanced or metastatic urothelial cancer, and approval in the earlier-stage perioperative setting could significantly broaden its clinical impact.
Industry analysts expect antibody-drug conjugates to remain one of the fastest-growing sectors within oncology therapeutics as pharmaceutical companies continue investing heavily in targeted biologic technologies. The EV-303 results may also influence future treatment guidelines by establishing combination ADC and immunotherapy regimens as potential standards of care for cisplatin-ineligible bladder cancer patients.
As precision oncology continues evolving through biomarker-driven therapies and advanced biologic platforms, the PADCEV and Keytruda combination represents another major step toward improving survival outcomes for patients facing aggressive and difficult-to-treat urothelial cancers.
Source: Astellas press release
