Clinical Scorecard: FDA approves durvalumab for bladder cancer
At a Glance
| Category | Detail |
|---|---|
| Condition | Muscle-invasive bladder cancer (MIBC) |
| Key Mechanisms | Neoadjuvant durvalumab plus enfortumab vedotin-ejfv, followed by adjuvant single-agent durvalumab after radical cystectomy. |
| Target Population | Adults with MIBC who are ineligible for or have refused cisplatin-based chemotherapy and are candidates for radical cystectomy. |
| Care Setting | Perioperative treatment around radical cystectomy. |
Key Highlights
- The FDA approved durvalumab with enfortumab vedotin-ejfv before radical cystectomy, followed by durvalumab alone after surgery.
- Approval followed the randomized, open-label VOLGA trial of 695 patients.
- Compared with radical cystectomy alone, the combination demonstrated statistically significant improvements in event-free and overall survival.
- Median event-free survival was not reached with the combination and was 12.1 months with surgery alone; median overall survival was not reached in either group.
- Common adverse reactions and laboratory abnormalities occurring in more than 20% included elevated AST and ALT, decreased hemoglobin, rash, pruritus, urinary tract infection, fatigue, diarrhea, nausea, and peripheral neuropathy.
Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Risks
Patient & Prescribing Data
Adults with MIBC who are candidates for radical cystectomy and are ineligible for or have refused cisplatin-based chemotherapy.
Durvalumab is given with neoadjuvant enfortumab vedotin-ejfv before surgery, then continued as adjuvant monotherapy. Durvalumab dosing is weight-based for patients under 30 kg.
Clinical Best Practices
Related Resources & Content
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