TOKYO, July 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for PADCEV™ (enfortumab vedotin) in combination with Keytruda® (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy.
The BLA is supported by results from the Phase 3 EV-303 and EV-304 clinical trials (KEYNOTE-905 and KEYNOTE-B15, respectively). In EV-303, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with surgery alone in MIBC patients ineligible for or who declined cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, the combination reduced the risk of tumor recurrence, progression, or death by 60%.1 In the Overall Survival (OS) analysis, the combination reduced the risk of death by 50%.1
In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the EFS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47%.2 In the OS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of death by 35%.2
In EV-303 and EV-304, the safety profile of enfortumab vedotin plus pembrolizumab was consistent with prior experience with the combination, and no new safety signals were observed.1,2 Across both trials, the most common (≥30%) adverse events (AEs) related to treatment with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab include pruritus (itching), alopecia, diarrhea, and anemia.1,2
According to the latest data from the China National Cancer Center, bladder cancer has an estimated incidence rate of 3.44 per 100,000 people, with more than 480,000 people affected in China.3,4 MIBC represents approximately 30% of bladder cancer cases, and despite curative-intent surgery, approximately half of MIBC patients experience recurrence.5,6
Astellas has already reflected the impact from this acceptance in its financial forecast of 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.7 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).7
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 in the United States.
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.
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 the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. 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, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes 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 BICR or death due to any cause. Key secondary endpoints include OS and pCR rate.
For more information on the global EV-304 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 muscle-invasive bladder cancer (MIBC). 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).
References
1. Vulsteke C, et al. Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer. N Engl J Med. 2026;394(13):1257-1269.
2. Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract #LBA630. 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Congress.
3. Han B, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 20242;4(1):47-53.
4. Worldometer. Countries in the world by population (2026). Available at: https://www.worldometers.info/world-population/population-by-country/. Last Accessed: March 2026.
5. Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/. Last Accessed: Last Accessed: June 2026.
6. Squires P, et al. 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;102466.
7. 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.