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FDA Approves AstraZeneca's Blockbuster Cancer Drug, Imfinzi, In Combination With Chemo For Non-Small Cell Lung Cancer

Friday, the FDA approved AstraZeneca Plc’s (NASDAQ:AZN) Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The FDA approval was based on the pivotal AEGEAN trial results published in The New England Journal of Medicine in October 2023. Also Read: AstraZeneca’s Blockbuster Cancer Drug Imfinzi Flunks As Follow-Up In Type Of Early-Stage Lung Cancer, But Hits Primary Goal In Phase 3 Bladder Cancer Study. Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen ...