AstraZeneca's Imfinzi granted priority review for cancer forms in US

(Alliance News) - AstraZeneca PLC on Monday said the US Food & Drug Administration has granted priority review for its immunotherapy drug Imfinzi for some cancer forms.

The Cambridge, England-based pharmaceutical company said the breakthrough therapy designation and priority review are for Imfinzi for treating patients with resectable early-stage gastric and gastroesophageal junction cancers.

This comes as the company's supplemental biologics license application for Imfinzi has been accepted by the US regulator.

AstraZeneca expects the FDA to make a regulatory decision in the fourth quarter of 2025.

Susan Galbraith, executive vice president for Oncology Haematology research & development at AstraZeneca said: "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. 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."

AstraZeneca in June had announced results on Imfinzi in combination with standard of care chemotherapy demonstrated significant and meaningful improvement in event-free survival in early stage gastric cancer, compared to chemotherapy alone.

The firm said patients treated with the Imfinzi-based regimen before, during and after surgery had a 29% reduction in the risk of disease progression, recurrence or death compared to chemotherapy alone. The results came from a planned interim analysis from the Matterhorn phase 3 trial.

AstraZeneca shares were up 0.8% to 10,888.00 pence on Monday morning in London.

By Tom Budszus, Alliance News slot editor

Comments and questions to newsroom@alliancenews.com

Copyright 2025 Alliance News Ltd. All Rights Reserved.

Astrazeneca