Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor
IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved 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. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).