AstraZeneca’s IMFINZI® Receives Breakthrough Therapy for Early Gastric and Gastroesophageal Cancers
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s regulatory filing for IMFINZI® (durvalumab) to treat patients with resectable, early-stage gastric and gastroesophageal junction (GEJ) cancers.
The application has been placed under Priority Review, with a decision anticipated in the final quarter of 2025.
In addition, IMFINZI has been granted Breakthrough Therapy Designation, a status given to medicines that show the potential for significant improvement compared with current standard treatments.
The submission is based on findings from the Phase III MATTERHORN study, which evaluated IMFINZI given alongside chemotherapy before surgery and continued as a post-surgical treatment.
Results demonstrated that this regimen lowered the risk of recurrence, disease progression, or death relative to chemotherapy alone, with benefits becoming more pronounced over time. Safety data were consistent with previously known profiles.
Gastric cancer remains the fifth most common cancer globally and a leading cause of cancer-related deaths.
Even with surgery and chemotherapy, many patients face relapse, underscoring the urgent need for better therapeutic options.
IMFINZI is an immunotherapy drug designed to strengthen the body’s immune response against cancer cells. It already holds approvals in multiple other cancers, including lung, bladder, biliary tract, liver, and endometrial cancers.
Since its first approval in 2017, more than 400,000 patients worldwide have been treated with IMFINZI.
AstraZeneca is continuing to invest in research across gastrointestinal cancers, with the goal of introducing immunotherapy earlier in treatment to reduce relapse risk and improve long-term outcomes for patients.
