AstraZeneca’s sBLA for Imfinzi granted priority review in U.S. for GEJ cancers

The company stated: “AstraZeneca’s (AZN) supplemental Biologics License Application, sBLA, for Imfinzi, durvalumab, has been accepted and granted Priority Review in the US for the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction, GEJ, cancers. The Food and Drug Administration (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.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2025.”