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AstraZeneca’s Imfinzi wins US approval for gastroesophageal cancer

ALN

AstraZeneca PLC on Tuesday said Imfinzi has been approved in the US as the first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers.

The Cambridge, England-based pharmaceuticals company said the approval follows priority review by the US Food & Drug Administration, and is based on event-free survival and overall survival data from the Matterhorn phase III trial.

The EFS results were presented during the plenary session at the 2025 American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine.

Overall survival results from Matterhorn were presented in a proffered paper session at the European Society for Medical Oncology Congress 2025.

Dave Fredrickson, executive vice president, Oncology Haematology Business Unit, AstraZeneca, said: ‘This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers.’

‘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.’

Shares in AstraZeneca closed down 0.4% at 13,884.00 pence each in London on Tuesday.

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