Global B2B Pharmaceutical Sourcing · Dossier Licensing · Named-Patient Access
💬 WhatsApp · Sign in · Register

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

Mitul Agarwal
Written by Mitul Agarwal · B.Pharm, MBA
Founder & Head of Business Development · 25+ years in international pharmaceutical BD&L
Published 29 November 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

Disclaimer: The information presented in this article is for informational and educational purposes only. While every effort has been made to ensure data accuracy and reliability, readers are advised to independently verify all figures, regulations, and market insights before making any business or investment decisions.
← Back to All Articles

 

Subscribe to Our Newsletter

Stay updated on pharma trends and sourcing opportunities.

Please enter the correct answer.
This website uses cookies to ensure you get the best experience. By using our site, you agree to our Privacy Policy.