FDA Expands Bladder Cancer Regimen
KEYNOTE-B15/EV-304 demonstrated statistically significant improvements in event-free and overall survival with perioperative pembrolizumab plus enfortumab vedotin-ejfv compared with neoadjuvant gemcitabine plus cisplatin.
By
Kathryn Wighton
July 10, 2026
Clinical Scorecard: FDA Expands Bladder Cancer Regimen
At a Glance
Category Detail
Condition Muscle-invasive bladder cancer Key Mechanisms Neoadjuvant treatment with pembrolizumab and enfortumab vedotin-ejfv Target Population Adults with muscle-invasive bladder cancer who are candidates for cystectomy Care Setting Oncology clinical practice
Key Highlights
FDA approved pembrolizumab with enfortumab vedotin-ejfv for neoadjuvant and adjuvant therapy Approval expands indication to all eligible adults, not just those ineligible for cisplatin Based on KEYNOTE-B15/EV-304 trial with 808 enrolled patients Median event-free survival not reached in pembrolizumab group; 48.5 months in gemcitabine plus cisplatin group Safety profile consistent with prior trials in urothelial cancer Guideline-Based Recommendations
Diagnosis
Management
Consider pembrolizumab plus enfortumab vedotin-ejfv as neoadjuvant treatment for eligible patients Monitoring & Follow-up
Risks
Warnings for immune-mediated adverse reactions, infusion-related reactions, and embryo-fetal toxicity for pembrolizumab Warnings for skin reactions, hyperglycemia, and embryo-fetal toxicity for enfortumab vedotin-ejfv Patient & Prescribing Data
Adults with muscle-invasive bladder cancer candidates for cystectomy
Combination therapy with pembrolizumab and enfortumab vedotin-ejfv shows promising efficacy
Clinical Best Practices
Utilize neoadjuvant therapy in eligible patients to improve surgical outcomes Monitor for adverse reactions associated with pembrolizumab and enfortumab vedotin-ejfv Related Resources & Content
