China’s CDE has accepted the biologics license application for PADCEV (enfortumab vedotin) plus Keytruda (pembrolizumab) as perioperative therapy in muscle‑invasive bladder cancer. Supported by EV‑303 and EV‑304 trial data, the filing could expand treatment options across cisplatin‑eligible and ineligible patients.
Written By: Mayuresh Salvi, PharmD
Reviewed By: Pharmacally Editorial Team
China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the biologics license application for PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as perioperative treatment for adults with muscle-invasive bladder cancer (MIBC). The application covers neoadjuvant treatment before cystectomy followed by adjuvant therapy after surgery, regardless of patients’ eligibility for cisplatin-containing chemotherapy.
The filing is backed by positive results from the pivotal Phase 3 EV-303 (KEYNOTE-905) and EV-304 (KEYNOTE-B15) trials, which demonstrated clinically meaningful improvements in event-free survival (EFS) and overall survival (OS). If approved, the regimen could expand perioperative treatment options for patients across a broad MIBC population in China.
ADC and Immunotherapy Combination Targets High-Risk Bladder Cancer
PADCEV is a first-in-class antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein highly expressed in urothelial cancers. After binding to Nectin-4, the antibody delivers the cytotoxic agent monomethyl auristatin E (MMAE) directly into tumor cells, inducing cell cycle arrest and apoptosis. Pembrolizumab complements this approach by restoring antitumor immune responses through PD-1 inhibition.
Bladder cancer remains a significant public health burden in China. According to the China National Cancer Center, the disease affects more than 480,000 people, with an estimated incidence of 3.44 cases per 100,000 population. Approximately 30% of patients present with muscle-invasive disease, and nearly half experience disease recurrence despite curative-intent surgery.
Phase 3 Trials Demonstrated Significant Survival Benefits
The regulatory submission combines evidence from two global Phase 3 studies evaluating perioperative enfortumab vedotin plus pembrolizumab in different patient populations.
EV-303 (KEYNOTE-905, NCT03924895) enrolled patients who were ineligible for or declined cisplatin-based chemotherapy. Compared with surgery alone, the combination reduced the risk of tumor recurrence, progression, or death by 60% in the EFS analysis and lowered the risk of death by 50% in the OS analysis.
EV-304 (KEYNOTE-B15, NCT04700124) evaluated the combination against standard neoadjuvant gemcitabine plus cisplatin chemotherapy in patients eligible for cisplatin. The investigational regimen reduced the risk of recurrence, progression, or death by 47% and reduced the risk of death by 35% compared with standard chemotherapy.
Across both studies, the safety profile remained consistent with previous experience for the combination, with no new safety signals identified. The most frequently reported treatment-related adverse events occurring in at least 30% of patients included pruritus, alopecia, diarrhea, and anemia.
Expanding a Growing Global Treatment Strategy
The acceptance marks another regulatory milestone for the PADCEV-Keytruda combination, which has already received approval in the United States as perioperative therapy for adults with MIBC who are ineligible for cisplatin-containing chemotherapy. The combination is also approved in multiple countries for locally advanced or metastatic urothelial cancer, while the European Union authorizes its use in platinum-eligible advanced disease.
Astellas stated that the latest regulatory acceptance has already been incorporated into its financial outlook for the fiscal year ending March 31, 2027. The company continues to work with regulatory authorities to expand the use of enfortumab vedotin plus pembrolizumab into earlier stages of bladder cancer, where reducing recurrence after surgery could substantially improve long-term patient outcomes.
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About the Writer
Mayuresh Sunil Salvi (Linkedin) is a PharmD professional and healthcare writer with a strong interest in pharmacovigilance, drug safety, and emerging medical research. He is passionate about exploring new drug discoveries, clinical research, and advances in evidence-based medicine. His interests also include ward rounds, prescription audits, and treatment analysis to support rational pharmacotherapy and improved patient care.