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- 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 -
TOKYO, May 22, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) 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).1
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.1
Bladder cancer is the 5th most common cancer in Europe, estimated to affect over 200,000 people a year.2 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.3
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.4,5,6
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.7
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 PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.9 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9
Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with la/mUC who are eligible for platinum-containing chemotherapy.
Enfortumab vedotin is also globally approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab or neoadjuvant and adjuvant pembrolizumab versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B) or neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab (arm C). Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.
The primary endpoint of this trial is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on imaging, blinded independent central review (BICR), and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.
For more information on the global EV-303 trial, go to clinicaltrials.gov.
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 urothelial cancer. 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).
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
References
1 Vulsteke C., et al. Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: phase 3 KEYNOTE-905 study. ESMO Congress 2025, Berlin, Germany; 17-21 Oct 2025. Abstract LBA2.
2 European Society of Urology. Bladder Cancer: The Forgotten Cancer. Available at: https://uroweb.org/news/bladder-cancer-the-forgotten-cancer. Date Accessed: April 2026
3 Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/#:~:text=When%20tumors%20grow%20into%20or,Virginia%20Health%20System%20explain%20MIBC. Date Accessed: April 2026.
4 Funt SA, Rosenberg JE. Systemic, perioperative management of muscle-invasive bladder cancer and future horizons. Nat Rev Clin Oncol. 2017 Apr;14(4):221-234. doi: 10.1038/nrclinonc.2016.188.
5 Esteban-Villarrubia J, Torres-Jiménez J, Bueno-Bravo C, García-Mondaray R, Subiela JD, Gajate P. Current and Future Landscape of Perioperative Treatment for Muscle-Invasive Bladder Cancer. Cancers (Basel). 2023 Jan 17;15(3):566. doi: 10.3390/cancers15030566.
6 Squires P, Cook EE, Song Y, Wang C, Zhang A, Seshasayee SM, Rogiers A, Li H, Mamtani R. Treatment Patterns, Disease Recurrence, and Overall Survival in Patients with Muscle-Invasive Bladder Cancer after Radical Cystectomy: A Population-Level Claims-Based Analysis. Clinical Genitourinary Cancer. 2025
7 European Medicines Agency. Authorization of Medicines. Available at: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. Date Accessed: April 2026.
8 Masson-Lecomte, A. et al. EAU Guidelines on Upper Urinary Tract Urothelial Carcinoma. Available at: https://uroweb.org/guidelines/upper-urinary-tract-urothelial-cell-carcinoma. Date Accessed: April 2026.
9 Challita-Eid PM., et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res 2016;76(10):3003-13.
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