FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER

Core Insights - The FDA has granted full approval to IMDELLTRA (tarlatamab-dlle) for treating adult patients with extensive stage small cell lung cancer (ES-SCLC) who have disease progression after platinum-based chemotherapy, marking it as a recognized standard of care [1][2][8] - The Phase 3 DeLLphi-304 trial demonstrated that IMDELLTRA reduced the risk of death by 40% and extended median overall survival by more than five months compared to standard chemotherapy [1][3][4] Company Developments - Amgen is committed to advancing IMDELLTRA for earlier stages of small cell lung cancer and earlier lines of therapy, emphasizing its dedication to providing transformative medicines for challenging cancers [2][3] - The safety profile of IMDELLTRA in the DeLLphi-304 trial showed fewer Grade 3 or greater adverse events compared to chemotherapy (54% vs 80%), indicating a favorable safety profile [2][3] Clinical Trial Insights - The DeLLphi-304 study involved 509 patients and was the first global Phase 3 trial to show a significant survival benefit over chemotherapy for ES-SCLC [3][4] - Key secondary outcomes of the trial included progression-free survival and patient-reported outcomes, which further support the efficacy of IMDELLTRA [4] Treatment Landscape - IMDELLTRA targets DLL3, a protein expressed on 85-96% of SCLC cells, making it a promising option for patients with limited treatment alternatives [7][8] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include tarlatamab as the only Category 1 preferred treatment option for this patient population [1][2] Future Directions - Amgen's development program for IMDELLTRA includes multiple ongoing clinical trials to evaluate its efficacy in various treatment settings, including combination therapies and earlier lines of treatment [5][6]