Imfinzi Bladder Combo Wins FDA Priority Review

The FDA has accepted AstraZeneca's application and granted Priority Review for IMFINZI plus enfortumab vedotin in muscle-invasive bladder cancer patients who cannot take or have declined cisplatin chemotherapy. A decision is expected in the fourth quarter of 2026. The filing rests on a Phase III VOLGA interim analysis that found statistically significant, clinically meaningful improvements in event-free survival and overall survival (time without recurrence or death, and total survival time) compared with radical cystectomy with or without approved follow-up treatment. Safety matched the known profiles of each drug; no new signals were seen. Susan Galbraith of AstraZeneca said the review reinforces IMFINZI's potential to become the immunotherapy backbone in this setting and, if approved, would be the first perioperative regimen with enfortumab vedotin given only before surgery, offering "practice-changing efficacy and tolerability." Roughly one in four bladder-cancer patients develop muscle-invasive disease, and up to half are ineligible for standard cisplatin regimens, leaving surgery as the main option while recurrence stays common. IMFINZI already holds related bladder-cancer approvals; EU, Japan and other regulators are reviewing the same data, with full trial results still to come.