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# Durvalumab Regimen OK’d for Gastroesophageal Cancer
- URL: https://www.fdaweb.com/durvalumab-regimen-okd-for-gastroesophageal-cancer/
- Published: 2025-11-26T12:00:00.000Z
- Updated: 2026-09-14T15:27:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160287

FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The regimen — durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) — will be used both before and after surgery, followed by single-agent durvalumab for up to 10 additional cycles. It marks the first immunotherapy-chemotherapy combination cleared in the U.S. for this setting, an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

FDA based the approval on data from the 948-patient MATTERHORN trial, a global, randomized, double-blind study evaluating the combination in previously untreated, resectable Stage II–IVA gastric or GEJ adenocarcinoma. Patients receiving durvalumab plus FLOT had significantly longer event-free survival than those receiving FLOT alone, the agency says. Median event-free survival had not yet been reached in the durvalumab arm, compared with 32.8 months in the control group, representing a 29% reduction in the risk of events, it adds.

Additionally, FDA says that overall survival also favored the durvalumab regimen, although medians were not reached in either arm at the time of analysis. The pathologic complete response rate more than doubled with durvalumab — 19.2% versus 7.2% on chemotherapy alone.

Imfinzi’s prescribing information carries warnings for immune-mediated adverse reactions, infusion reactions, complications following allogeneic stem-cell transplantation, and embryo-fetal toxicity.