Reported November 19, 2025: Amgen's IMDELLTRA Receives FDA Approval For Extensive Stage Small Cell Lung Cancer After Phase 3 Trial Shows 40% Reduction In Death Risk Compared To Chemotherapy

Author: Benzinga Newsdesk | November 20, 2025 09:45am

Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy

Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed

THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA's prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were recently updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.1* 

The global Phase 3 DeLLphi-304 study met its primary endpoint, demonstrating that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001).2  

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