Objective:

The article examines the objective, findings, and clinical context described in FDA approves durvalumab for bladder cancer.

Approach:

• Approval: The FDA approved neoadjuvant durvalumab plus enfortumab vedotin-ejfv, followed by adjuvant single-agent durvalumab after radical cystectomy.
• Evidence: Approval followed the randomized, open-label VOLGA trial, which assigned 695 patients to one of three treatment groups.
• Regimen: For patients weighing at least 30 kg, the regimen is durvalumab 1,500 mg every 3 weeks with enfortumab vedotin-ejfv 1.25 mg/kg on days 1 and 8 for three presurgical cycles, followed by durvalumab every 4 weeks for up to nine postoperative cycles. For patients …

Key Findings:

• 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; the combination showed a statistically significant survival advantage.
• Adverse reactions and laboratory abnormalities occurring in more than 20% of patients included elevated AST and ALT, decreased hemoglobin, rash, pruritus, urinary tract infection, fatigue, diarrhea, nausea, and peripheral neuropathy.

Interpretation:

The FDA announced the approval on November 13, 2026. The application received priority review and was approved six weeks before the FDA goal date under Project Orbis.

Limitations:

• The provided context does not report numerical hazard ratios, confidence intervals, or p-values.
• The provided context does not describe results for the third investigational treatment group.

Sources:

• FDA