Wire · operational-macro
FDA Approves Durvalumab Plus EV Before Surgery in Cisplatin-Ineligible MIBC
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 14 November 2026 · Fusion42 review
The FDA approved the combination of durvalumab plus enfortumab vedotin (EV) before surgery as a perioperative treatment for muscle-invasive bladder cancer (MIBC) in patients ineligible for or refusing cisplatin chemotherapy. This approval is based on phase 3 VOLGA trial results showing significant reductions in risk of recurrence and death compared to surgery alone.
This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it.
◆ ◆ The Wire takeaway
You must prepare for a shift in bladder cancer treatment standards as the FDA now endorses a new perioperative chemo-immunotherapy regimen that sidelines cisplatin for many patients. If you work with therapies or diagnostics for MIBC, this changes patient eligibility and treatment pathways immediately.
◆ Coverage
6 sources · 13 Nov 2026
◆ Related on Wire
◆ Topics