Imfinzi granted Breakthrough status for gastric and GEJ cancers in USA

UK pharma major AstraZeneca (LSE: AZN) this morning revealed that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the USA for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) 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. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date or their regulatory decision, is anticipated during the fourth quarter of 2025. Imfinzi was also recently granted Breakthrough Therapy designation (BTD) by the FDA in this setting.