US EditionAstraZeneca Wins FDA Nod For Imfinzi Combination Regimen In Tough-To-Treat Stomach Cancers - AstraZeneca (NASDAQ:AZN)
The FDA approved Imfinzi with FLOT chemotherapy after the MATTERHORN trial showed a 22% reduction in death risk and 69% three-year survival for gastric and GEJ cancer patients.
- On November 26, 2025, the Food and Drug Administration, United States approved AstraZeneca plc's Imfinzi with FLOT chemotherapy following Priority Review and MATTERHORN Phase III trial data.
- Final trial results demonstrated the MATTERHORN Phase III trial’s overall survival analysis showed Imfinzi plus FLOT reduced death risk by 22% with hazard ratio 0.78 and CI 0.63-0.96.
- AstraZeneca said the approved perioperative course prescribes neoadjuvant Imfinzi plus FLOT chemotherapy, followed by adjuvant Imfinzi plus FLOT and then Imfinzi monotherapy, marking its third U.S. perioperative durvalumab approval.
- Roughly 6,500 patients in 2024 may be eligible, reflecting the United States patient population, while AstraZeneca shares were trading near $93.41 on Tuesday.
- Longer follow-up showed continued OS curve separation with three‑year survival estimates of 69% versus 62% and a planned interim analysis showing 29% reduction in progression risk.
12 Articles
12 Articles
FDA OKs Perioperative Immunotherapy for Stomach Cancer
(MedPage Today) -- The FDA approved perioperative durvalumab (Imfinzi) in combination with a multidrug chemotherapy regimen for resectable gastric or gastroesophageal junction cancer, the agency announced on Tuesday. Approval stipulates use of...
AstraZeneca Wins FDA Nod For Imfinzi Combination Regimen In Tough-To-Treat Stomach Cancers - AstraZeneca (NASDAQ:AZN)
FDA approves AstraZeneca's Imfinzi plus FLOT for early gastric and GEJ cancers after Phase 3 data show strong event-free and overall survival benefits.
AstraZeneca Imfinzi gets USFDA okay for early gastric and gastroesophageal cancers
Cambridge: AstraZeneca has announced that Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has received approval from...
FDA OKs Perioperative Immunotherapy for Stomach Cancer
(MedPage Today) — The FDA approved perioperative durvalumab (Imfinzi) in combination with a multidrug chemotherapy regimen for resectable gastric or gastroesophageal junction cancer, the agency announced on Tuesday. Approval stipulates use of… Source link : https://www.medpagetoday.com/hematologyoncology/othercancers/118746 Author : Publish date : 2025-11-26 17:46:00 Copyright for syndicated content belongs to the linked Source. The post FDA OKs…
AstraZeneca’s Imfinzi Wins U.S. Approval for Perioperative Gastric Cancer Treatment with FLOT
AstraZeneca announced that the FDA approved Imfinzi (durvalumab) with the standard FLOT chemotherapy regimen for adults with resectable stage II, III, or IVA gastric and … AstraZeneca’s Imfinzi Wins U.S. Approval for Perioperative Gastric Cancer Treatment with FLOT Read More » The post AstraZeneca’s Imfinzi Wins U.S. Approval for Perioperative Gastric Cancer Treatment with FLOT first appeared on GeneOnline News. The post AstraZeneca’s Imfinzi Wi…
AstraZeneca Wins US Approval For Imfinzi In Early Gastric And GEJ Cancers
AstraZeneca plc (LON:AZN)’s Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, fo…
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