European Commission approves PADCEV as perioperative treatment for cisplatin-ineligible patients with resectable MIBC

CAR-T Digest - August 2020

Weekly Digest - June 2026

24 June 2026: European Commission approves PADCEV as perioperative treatment for cisplatin-ineligible patients with resectable MIBC

Astellas and Pfizer have received European Commission approval for PADCEV in combination with KEYTRUDA as neoadjuvant treatment followed by adjuvant therapy after surgery for patients with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy, establishing the first and only approved perioperative treatment option for this patient population in the European Union
The approval was supported by results from the phase 3 EV-303/KEYNOTE-905 trial, where perioperative PADCEV plus pembrolizumab reduced the risk of recurrence, progression, or death by 60% versus surgery alone (EFS HR=0.40) and lowered the risk of death by 50% (OS HR=0.50). The combination also achieved a markedly higher pathological complete response rate of 57.1% compared with 8.6% for surgery alone, demonstrating substantial clinical benefit in cisplatin-ineligible patients with resectable muscle-invasive bladder cancer
The decision addresses a major unmet need in muscle-invasive bladder cancer, where cisplatin-ineligible patients have historically faced limited perioperative treatment options and remain at high risk of recurrence and progression despite curative-intent surgery
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 approach that combines targeted cytotoxicity with immune-mediated anti-tumor activity
Strategically, the approval expands PADCEV’s role beyond metastatic urothelial cancer into earlier-stage disease, strengthens Astellas and Pfizer’s leadership in bladder cancer, and further validates ADC-immunotherapy combinations as an emerging perioperative treatment paradigm capable of reshaping standards of care in uro-oncology