AstraZeneca gets priority review for bladder cancer drug

• AstraZeneca received U.S. FDA Priority Review for IMFINZI plus enfortumab vedotin as a potential treatment for certain muscle-invasive bladder cancer patients.
• The application is based on Phase III VOLGA trial results showing improvements in event-free survival and overall survival compared with surgery-based treatment.
• AstraZeneca said the combination could provide an additional treatment option for patients unable to receive or who decline cisplatin-based chemotherapy.

AstraZeneca (NASDAQ:AZN) received U.S. Food and Drug Administration Priority Review for its supplemental Biologics License Application for IMFINZI (durvalumab) combined with enfortumab vedotin in patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy.

The FDA review follows results from the Phase III VOLGA trial, where perioperative treatment with IMFINZI plus neoadjuvant enfortumab vedotin showed improvements in event-free survival and overall survival compared with radical cystectomy with or without approved adjuvant treatment.

“This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca.

The FDA’s Priority Review designation sets an expected regulatory decision date in the fourth quarter of 2026, while AstraZeneca said regulatory applications based on VOLGA results are also under review in the European Union, Japan, and other countries.

AstraZeneca develops medicines across oncology, cardiovascular, respiratory, and other therapeutic areas, with IMFINZI being an immunotherapy treatment approved for multiple cancer indications.

The company said IMFINZI is approved in more than 50 countries for certain patients with muscle-invasive bladder cancer and is also approved in other bladder cancer settings based on results from previous Phase III trials.