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FDA Approves Durvalumab With Enfortumab Vedotin for MIBC

Published

13 November 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at medscape.com →

◆ Verified

Fusion42 · 13 November 2026 · Fusion42 review

The FDA approved durvalumab combined with enfortumab vedotin as neoadjuvant treatment followed by adjuvant durvalumab for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin chemotherapy, based on improved event-free and overall survival in the VOLGA trial.

This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it.

◆ ◆ The Wire takeaway

You now have a new FDA-approved drug combo for MIBC that opens a path to market if cisplatin chemo is off the table. Clinical-stage biotech founders in oncology must fast-track strategies around durvalumab and enfortumab vedotin use.

◆ Coverage

6 sources · 13 Nov 2026

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◆ Topics

Biotechfda-approvalcancer-treatmentbladder-canceroncologyimmunotherapy