The U.S. Food and Drug Administration (FDA) on Tuesday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

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The approved regimen includes neoadjuvant (therapy before surgery) Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.

The approval follows FDA's Priority Review and is based on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase 3 trial.

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