FDA Approves IMFINZI-Based Perioperative Regimen for Cisplatin-Ineligible Bladder Cancer
AZN sits 20% above its 52-week low of $153.413.
Summary
The FDA approved IMFINZI plus enfortumab vedotin as neoadjuvant treatment followed by IMFINZI monotherapy after surgery for muscle-invasive bladder cancer patients who can't take or refuse cisplatin chemotherapy. The approval came with Priority Review and rests on the VOLGA Phase III trial, where the regimen cut the risk of progression, recurrence, missed surgery or death by 49% (EFS HR 0.51) and reduced the risk of death by 42% (OS HR 0.58). Roughly 16,000 US patients are treated for MIBC in 2026, and as many as half are cisplatin-ineligible, so this opens a meaningful slice of the curative-intent setting where radical cystectomy alone was the prior standard. It is AstraZeneca's third bladder cancer indication in two years and extends IMFINZI as the immunotherapy backbone across muscle-invasive and non-muscle-invasive disease. Regulatory filings based on VOLGA are under review in the EU, Japan and other countries, which is the next milestone to track.
At the time of this announcement, AZN was trading at $184.45 on NYSE in the Life Sciences sector, with a market capitalization of approximately $286.1B. The 52-week trading range was $153.41 to $212.71. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.