FDA Grants Priority Review To AstraZeneca’s Imfinzi For Early-Stage Gastric And Gastroesophageal Junction Cancers

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in treating patients with resectable, early-stage, and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. This status accelerates the FDA’s review timeline, recognizing the potential of Imfinzi to offer significant advancements over current treatments. The FDA’s decision is expected by the fourth quarter of 2025. Imfinzi has also received Breakthrough Therapy Designation (BTD) for this setting, which further streamlines its regulatory path.

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 MATTERHORN trial evaluated a perioperative regimen of Imfinzi plus chemotherapy given before and after surgery, followed by Imfinzi monotherapy. The interim analysis revealed that there was a 29 percent risk reduction in the chances of progress, recurrence, or death as opposed to the use of chemotherapy alone. The Imfinzi-based regimen also indicated a higher cumulative event-free survival (EFS) ratio at 12 and 24 months, indicating a potential practice-altering clinical advantage. There appeared to be a trend towards a better overall survival (OS) that will be evaluated in the concluding analysis. 

Imfinzi combined with FLOT chemotherapy was well-tolerated, and its safety profile remained consistent with known data. The percentage of patients able to undergo surgery was comparable to those receiving chemotherapy alone. Regulatory submissions based on the MATTERHORN trial are underway in the EU, Japan, and several other regions.