AstraZeneca’s Imfinzi wins EU-first immunotherapy approval in early GI cancers
The approval represents the pharmaceutical company’s third perioperative approval in Europe for an Imfinzi-based regimen.
The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) alongside chemotherapy as the first perioperative immunotherapy for early gastric and gastroesophageal cancers.
The regimen comprises the monoclonal antibody in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) in adults with Stages II, III, IVA, gastric and gastroesophageal junction (GEJ) cancers. This involves two cycles prior to and post surgery, then Imfinzi monotherapy.
The approval is based on positive data from the Matterhorn Phase III trial, published in the NEJM. Its authorisation follows the CHMP’s decision on the regimen in February.
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