AstraZeneca granted priority review for Imfinzi BLA

AstraZeneca’s (AZN) supplemental biologics license application for Imfinzi has been accepted and granted priority review in the U.S, for the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The FDA grants priority review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2025. Imfinzi was also recently granted Breakthrough Therapy Designation by the FDA in this setting.