FDA Approves Padcev plus Keytruda for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
核心洞察
The CHMP has adopted a positive opinion recommending enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer (搜索) in the EU.
The opinion rests on Phase 3 EV-304 data showing a 47% reduction in risk of recurrence, progression or death and a 35% reduction in risk of death versus gemcitabine-cisplatin.
If the European Commission approves, the MIBC indication would extend from cisplatin-ineligible patients to all adults with resectable disease regardless of cisplatin eligibility.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) has adopted a positive opinion recommending approval of PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer (搜索) (MIBC) in the European Union. Astellas said the opinion is based on the Phase 3 EV-304 trial (KEYNOTE-B15), in which perioperative enfortumab vedotin plus pembrolizumab improved event-free survival and overall survival versus standard-of-care neoadjuvant gemcitabine and cisplatin in cisplatin-eligible patients.
In EV-304, the combination reduced the risk of tumor recurrence, progression or death by 47% (HR 0.53; 95% CI, 0.41-0.70; 1-sided p<0.0001) and reduced the risk of death by 35% (HR 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029). Grade 3 or higher adverse events from any cause occurred in 75.7% of patients on the combination versus 67.2% on neoadjuvant chemotherapy, and the safety profile was consistent with the known profiles of the individual medicines with no new safety signals. Results were recently published in The New England Journal of Medicine.
Enfortumab vedotin plus pembrolizumab was approved by the European Commission in June 2026 as neoadjuvant and adjuvant treatment for cisplatin-ineligible adults with resectable MIBC. Approval in this setting would extend the indication to cisplatin-eligible patients, covering adults with resectable MIBC regardless of cisplatin eligibility. The European Commission is expected to issue a final decision within approximately two months, applying to all 27 EU member states plus Iceland, Liechtenstein and Norway. PADCEV is a first-in-class antibody-drug conjugate directed against Nectin-4 (搜索).
Source: Astellas newsroom