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
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