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FDA Approves Perioperative Durvalumab/Enfortumab Vedotin in MIBC
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Fusion42 · 13 November 2026 · Fusion42 review
The FDA approved perioperative use of durvalumab with neoadjuvant enfortumab vedotin for muscle-invasive bladder cancer patients ineligible for or declining cisplatin chemotherapy, based on phase 3 VOLGA trial results demonstrating improved event-free and overall survival.
This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it.
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You can now position new bladder cancer treatments around approved perioperative durvalumab and enfortumab vedotin combinations, which open access to patients unsuitable for cisplatin. This approval creates a clear regulatory precedent and market entry point in muscle-invasive bladder cancer care.
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6 sources · 13 Nov 2026
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