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FDA Approves Perioperative Durvalumab Plus Enfortumab Vedotin-ejfv for MIBC
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Fusion42 · 14 November 2026 · Fusion42 review
The FDA approved durvalumab in combination with enfortumab vedotin as a perioperative treatment for muscle-invasive bladder cancer (MIBC) patients ineligible for or refusing cisplatin chemotherapy, based on the positive results from the global phase 3 VOLGA trial showing significant improvements in event-free survival and overall survival.
This Wire brief sits within Fusion42's coverage of Biotech, and 7 sources have reported it between 13 Nov 2026 and 14 Nov 2026.
◆ ◆ The Wire takeaway
You must reset your treatment plans for bladder cancer patients who can’t receive cisplatin. The FDA’s new approval opens direct market access for perioperative immunotherapy combined with enfortumab vedotin, bypassing traditional chemo reliance.
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7 sources · first reported 13 Nov 2026 · latest 14 Nov 2026
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