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Imfinzi approved in EU for AEGEAN
Imfinzi approved in EU for AEGEAN.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n04 April 2025\n \nImfinzi-based perioperative regimen approved in the EU for\nresectable non-small cell lung cancer\n \n Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone\n \nAstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.\n \nThe approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine.\n \nEach year in Europe, there are more than 450,000 people diagnosed with lung cancer.1 Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed at an early stage to have surgery with curative intent.2-3 However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years.4-5 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.4\n \nProfessor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and investigator in the trial, said: \"Today's approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable non-small cell lung cancer, who have historically faced high rates of recurrence and a poor prognosis. When added to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.\"\n \nDave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: \"Today...