WILMINGTON, DE — AstraZeneca’s (NYSE: AZN) application to expand Imfinzi into another form of bladder cancer has received FDA Priority Review after a Phase III trial showed the drug combination improved both event-free and overall survival for patients unable or unwilling to receive cisplatin-based chemotherapy.
The Food and Drug Administration accepted the supplemental Biologics License Application for Imfinzi, or durvalumab, in combination with enfortumab vedotin for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin treatment.
A regulatory decision is expected in the fourth quarter of 2026 under the Prescription Drug User Fee Act timetable.
The application is based on AstraZeneca’s VOLGA Phase III trial. At a planned interim analysis, perioperative Imfinzi combined with enfortumab vedotin before surgery produced statistically significant and clinically meaningful improvements in event-free survival and overall survival compared with radical cystectomy, with or without approved treatment following surgery.
Detailed results from VOLGA have not yet been presented and are scheduled for disclosure at a forthcoming medical meeting.
AstraZeneca said the combination’s safety and tolerability were consistent with the established profiles of the individual medicines, with no new safety signals identified.
The potential indication targets a group with limited treatment options. About one-quarter of bladder cancer patients have muscle-invasive disease without distant metastases, according to figures cited by AstraZeneca, and as many as half may be unable to receive cisplatin because of impaired kidney function or other medical conditions.
Those patients have historically been treated with radical cystectomy alone, leaving a need for therapies capable of reducing the risk of recurrence around surgery.
“If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery,” Susan Galbraith, AstraZeneca’s executive vice president for oncology hematology research and development, said.
Priority Review is used by the FDA for applications involving therapies that could provide significant improvements in treating or preventing serious conditions. The designation accelerates regulatory review but does not constitute approval.
AstraZeneca is also seeking approval for the VOLGA regimen in the European Union, Japan and other markets.
Imfinzi is already approved in more than 50 countries for cisplatin-eligible muscle-invasive bladder cancer based on the Phase III NIAGARA trial. The drug is also approved with Bacillus Calmette-Guérin therapy in the U.S., Japan and other countries for certain patients with high-risk non-muscle-invasive bladder cancer.
AstraZeneca reported in July that another Phase III study, NILE, found Imfinzi plus chemotherapy improved overall survival compared with chemotherapy alone as a first-line treatment for patients with PD-L1-high unresectable, locally advanced or metastatic urothelial cancer.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.