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The FDA has approved durvalumab (Imfinzi) plus enfortumab vedotin (Padcev) as a perioperative regimen for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin. Backed by the phase 3 VOLGA trial, the doublet cut the risk of disease progression or death by 49% and improved 24-month overall survival to 78% vs. 69% with surgery alone — a meaningful win for a patient population with historically poor outcomes.
The FDA has approved durvalumab (Imfinzi) combined with enfortumab vedotin (Padcev) as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant therapy after radical cystectomy, for adults with muscle-invasive bladder cancer (MIBC) who cannot receive or have declined cisplatin-based chemotherapy. The approval marks a significant shift for a population that previously had few systemic options beyond surgery.
The decision was driven by data from the phase 3 VOLGA trial (n=695), which showed the doublet regimen dramatically outperformed surgery alone on both key endpoints. Notably, a triplet regimen adding tremelimumab improved event-free survival but did not reach statistical significance for overall survival at the interim analysis — so the FDA approval applies only to the durvalumab/enfortumab vedotin doublet.
By the Numbers:
Why it matters: Up to half of MIBC patients are ineligible for cisplatin and face high recurrence rates even after bladder removal. This approval offers a new, cisplatin-free perioperative standard of care with proven survival benefits — a potentially practice-changing option in a curative-intent setting.
