07:35 AM EST, 12/06/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Friday that the US Food and Drug Administration granted priority review for a supplemental biologics license application for Imfinzi as a treatment for patients with muscle-invasive bladder cancer.

The company said a priority review is granted to applications for medicines that would "offer significant improvements" over other treatment options.

According to AstraZeneca ( AZN ), the application was based on data from a phase 3 trial in which a combination therapy that included Imfinzi demonstrated significant event-free and overall survival benefit.

The FDA's action date for its regulatory decision is expected in Q2 and AstraZeneca ( AZN ) said regulatory applications are also under review in Japan, the EU, and other countries based on the results of the trial.