FDA Approves Durvalumab (Imfinzi) + FLOT Regimen for Resectable Gastric & GEJ Cancer

Written by PharmaTradz Editorial Team

November 29, 2025

The U.S. FDA has given the green light to AstraZeneca’s durvalumab (Imfinzi) in combination with the FLOT chemotherapy regimen as a perioperative treatment for adults suffering from resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval is for both neoadjuvant and adjuvant use and will thus establish a new immunotherapy-based standard of care for patients undergoing curative surgery. The full prescribing information will subsequently be integrated into the Drugs@FDA database after the label updates.

Source Reference:

FDA Official Press Release:
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-durvalumab-flot-gastric-gej-adenocarcinoma

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