AstraZeneca announces new FDA indication approval for IMFINZI® (durvalumab)
On December 2nd, 2025
US approval of AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) 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, followed by adjuvant IMFINZI in combination with chemotherapy, then IMFINZI monotherapy. The approval follows Priority Review by the FDA and is based on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. For additional information, please see the press release here.
US approval of AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) 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, followed by adjuvant IMFINZI in combination with chemotherapy, then IMFINZI monotherapy. The approval follows Priority Review by the FDA and is based on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. For additional information, please see the press release here.
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