LONDON (dpa-AFX) - AstraZeneca (AZN, AZN.L) said its Imfinzi, or durvalumab, in combination with standard-of-care FLOT chemotherapy has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.
The approval follows Priority Review by the FDA and is based on event-free survival and overall survival data from the MATTERHORN Phase III trial. The company noted that the US regulatory submission was reviewed under Project Orbis.
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