Durvalumab stories

Nov 13, 2026

FDA approves durvalumab plus enfortumab vedotin for muscle-invasive bladder cancer

The FDA approved AstraZeneca's durvalumab combined with enfortumab vedotin as neoadjuvant treatment followed by adjuvant durvalumab after radical cystectomy for muscle-invasive bladder cancer. The approval adds a new perioperative immunotherapy option for this high-risk cancer.

Nov 13, 20262 sources

Top claims

▪In the phase 3 VOLGA trial, neoadjuvant durvalumab plus enfortumab vedotin achieved an estimated 24-month event-free survival rate of 63.5% compared to 45.1% with radical cystectomy alone
▪In the phase 3 VOLGA trial, grade 3 or higher adverse events occurred in 71.1% of muscle-invasive bladder cancer patients receiving durvalumab plus enfortumab vedotin compared to 50.2% undergoing surgery alone
▪In the phase 3 VOLGA trial, pathologic complete response by local review was achieved in 45.1% of patients receiving durvalumab plus enfortumab vedotin versus 9.6% with radical cystectomy alone

Topics

FDA drug approval Cancer treatment Cancer & Oncology Clinical trials Cancer and Cancer Treatment Cancer treatment breakthroughs Cancer immunotherapy Drug Policy, Pricing & Approval Oncology

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