AstraZeneca’s sBLA for IMFINZI Accepted and Granted Priority Review

AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI (durvalumab) has been accepted and granted Priority Review in the U.S. 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.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “This Priority Review reinforces the potential for a perioperative approach with IMFINZI to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy. This novel treatment is the only immunotherapy-based regimen to show a statistically significant reduction in the risk of progression, recurrence or death in this setting, and if approved, is poised to change the clinical paradigm.”

The sBLA is based on data from the MATTERHORN Phase III trial which was presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

Regulatory applications are currently under review in the EU, Japan, and several other countries based on the MATTERHORN results.

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