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.
Three amino acid metabolism genes showed diagnostic signal in testicular tissue, though small sample sizes and computational methods limit clinical translation.
A combination of PSA density, MRI, and PSMA PET findings identified a small subgroup with adverse pathology, supporting further study of biopsy-sparing pathways.
