FDA Grants Priority Review for Imfinzi in MIBC Treatment

AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review by the U.S. FDA for treating muscle-invasive bladder cancer (MIBC). This designation reflects the therapy's potential to improve patient outcomes in a challenging setting where existing treatments often lead to recurrence or poor prognosis.

The application is supported by Phase III NIAGARA trial data showing that Imfinzi, combined with neoadjuvant chemotherapy and followed by adjuvant monotherapy, reduced disease progression risks by 32% and improved survival rates. Regulatory decisions are anticipated in mid-2025.