The FDA has granted priority review to a supplemental biologics license application for durvalumab (Imfinzi) combined with enfortumab vedotin (Padcev) as a perioperative regimen for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. If approved, this would be the first perioperative regimen featuring enfortumab vedotin given only before surgery — a potential new standard of care in a curative-intent setting.

The application is anchored in data from the phase 3 VOLGA trial, which enrolled 695 patients across three arms. The trial showed that perioperative durvalumab plus neoadjuvant enfortumab vedotin significantly improved both event-free survival (EFS) and overall survival (OS) compared to standard of care (radical cystectomy ± approved adjuvant treatment), with a manageable safety profile and no new signals.

Key Takeaways:

• Up to half of MIBC patients are cisplatin-ineligible, leaving a major treatment gap this regimen aims to fill
• The VOLGA trial's dual primary endpoints were EFS for both experimental arms vs. the comparator
• Regulatory applications are also under review in the EU, Japan, and other countries
• Full trial data will be presented at an upcoming medical meeting

Why it matters: Bladder cancer patients who can't tolerate cisplatin face high recurrence rates even after surgery. This priority review signals a potentially practice-changing shift — offering an effective, well-tolerated perioperative option where few currently exist.