Priority review for perioperative durvalumab plus enfortumab vedotin in cisplatin-ineligible MIBC

FDA priority review · Urology Times · 2026-09-25. Number 1 in the UrologyWatch Top 5 for September 26, 2026.

Based on phase 3 VOLGA, where the regimen improved event-free and overall survival versus cystectomy with or without adjuvant therapy. FDA decision expected Q4 2026.

Why it matters: Would give cisplatin-ineligible patients a second perioperative immunotherapy-ADC option alongside EV-pembrolizumab.

Source: Urology Times

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