India Pharma Outlook Team | Thursday, 27 November 2025
AstraZeneca’s Imfinzi has received US approval today for use with FLOT chemotherapy in adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
The regimen includes Imfinzi before surgery, followed by continued treatment after surgery and then Imfinzi monotherapy, creating a clear update to current treatment practice.
The approval followed priority review by the FDA and relied on results from the phase III MATTERHORN trial. In the study, the Imfinzi-based regimen cut the risk of disease progression, recurrence or death by 29% compared with chemotherapy alone.
Median event-free survival was not yet reached for the Imfinzi arm, while the control arm reached 32.8 months. In overall survival, 69% of patients on the Imfinzi regimen were alive at three years, compared with 62% on FLOT alone.
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Dave Fredrickson, AstraZeneca’s executive vice president of the oncology haematology business unit, said: “This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers… this milestone further validates the perioperative approach.” Lead investigator Yelena Y. Janjigian, MD, said the results show a clear overall survival benefit in both gastric and GEJ cancers, calling it the first immunotherapy approved in the neoadjuvant setting for this group of patients. Aki Smith, founder of Hope for Stomach Cancer, said the decision brings needed progress for patients who face a high chance of recurrence even after surgery.
The safety profile for Imfinzi with FLOT matched known effects, and surgery completion rates were similar between both groups. The submission was also reviewed under Project Orbis, with ongoing reviews in Australia, Canada, Switzerland, the EU, Japan and other regions.
With rising global cases, today’s approval strengthens the position of Imfinzi in early gastric and GEJ cancer treatment.
