China’s NMPA administration accepts Biologics License Application for PADCEV plus Keytruda in Muscle-Invasive Bladder Cancer

CAR-T Digest - August 2020

Weekly Digest - July 2026

7 July 2026: China’s NMPA administration accepts Biologics License Application for PADCEV plus Keytruda in Muscle-Invasive Bladder Cancer

Astellas have announced that China’s National Medical Products Administration has accepted the Biologics License Application for PADCEV in combination with KEYTRUDA as perioperative treatment for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, marking another significant regulatory milestone for the ADC-immunotherapy combination in early-stage bladder cancer
The submission is supported by the Phase III EV-303/KEYNOTE-905 and EV-304/KEYNOTE-B15 trials, where perioperative PADCEV plus pembrolizumab significantly improved event-free survival and overall survival versus standard treatment, reducing the risk of recurrence, progression, or death by 60% (EFS HR=0.40) in EV-303 and 47% (EFS HR=0.53) in EV-304, while achieving pathological complete response rates of 57.1% and 55.8%, respectively
If approved, the combination would become the first perioperative ADC-based regimen available in China for patients with resectable MIBC, expanding treatment options for a high-risk population that has historically faced limited alternatives, particularly those ineligible for cisplatin-based chemotherapy
PADCEV is a Nectin-4-directed antibody-drug conjugate (ADC) that delivers the microtubule-disrupting payload MMAE directly to tumor cells, while pembrolizumab provides PD-1 checkpoint inhibition, creating a complementary ADC-immunotherapy approach designed to improve long-term outcomes in earlier-stage bladder cancer
Strategically, the BLA acceptance further expands the global regulatory momentum of PADCEV beyond metastatic urothelial carcinoma into perioperative muscle-invasive disease, strengthening Astellas and Pfizer’s leadership in bladder cancer while reinforcing ADC-immunotherapy combinations as an emerging standard of care in earlier treatment settings