AstraZeneca has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

The FDA assigns Priority Review to medicines that may offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.

A regulatory decision is expected in the fourth quarter of 2025 under the Prescription Drug User Fee Act (PDUFA).

Imfinzi was also recently awarded Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

“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,” said Susan Galbraith, Executive Vice President, Oncology Haematology R and D, AstraZeneca.

“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,” she added.

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality. Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.

The sBLA is supported by data from the Phase III MATTERHORN trial, which evaluated a perioperative regimen of Imfinzi plus chemotherapy before and after surgery, followed by Imfinzi monotherapy.

At an interim analysis, the Imfinzi-based regimen demonstrated a 29 percent reduction in the risk of disease progression, recurrence, or death compared to chemotherapy alone. Regulatory reviews based on the MATTERHORN trial are ongoing in the European Union, Japan, and other global markets.