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FDA Approves Durvalumab-Enfortumab Vedotin for Cisplatin-Ineligible MIBC
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Fusion42 · 13 November 2026 · Fusion42 review
The FDA approved the combination of durvalumab and enfortumab vedotin as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC) ineligible for cisplatin chemotherapy, following the phase 3 VOLGA trial that showed a 49% reduction in event-free survival events and a 42% reduction in death risk.
This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it.
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You now have a new FDA-approved treatment option for muscle-invasive bladder cancer patients who cannot use cisplatin. This opens the door to new therapies and clinical approaches in bladder cancer care.
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6 sources · 13 Nov 2026
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