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AstraZeneca secures US approval for Imfinzi in gastric cancer

Wed 26 Nov 2025 07:03

(Sharecast News) - Drugmaker AstraZeneca said on Wednesday that its Imfinzi asset has been approved in the US for use alongside standard FLOT chemotherapy in the treatment of adult patients with resectable, early‑stage and locally advanced gastric and gastroesophageal junction cancers. AstraZeneca said the regimen covers neoadjuvant Imfinzi with chemotherapy ahead of surgery, followed by adjuvant Imfinzi with chemotherapy and then Imfinzi monotherapy.

The FTSE 100-listed firm stated approval from the Food and Drug Administration followed a Priority Review and was based on event‑free and overall survival data from its Phase III MATTERHORN trial.

Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology business unit, said: "This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers, with Imfinzi plus FLOT delivering a durable survival benefit that increases over time.

"As the third US approval for a perioperative Imfinzi-based regimen, this milestone further validates the perioperative approach and underscores our focus on bringing novel treatments to early-stage cancers where cure is the goal."

Reporting by Iain Gilbert at Sharecast.com

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