Amgen announced that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after platinum-based chemotherapy. This approval, granted under the FDA’s accelerated approval program, is based on promising response rates and duration of response observed in clinical studies. Continued approval may depend on verification of clinical benefits in confirmatory trials. IMDELLTRA is the first and only DLL3-targeting bispecific T-cell engager therapy that activates T cells to attack DLL3-expressing tumor cells.

Jay Bradner, MD, Amgen’s executive vice president of research and development and chief scientific officer, emphasized the transformative impact of IMDELLTRA, marking a significant advancement for patients with ES-SCLC. David P. Carbone, MD, PhD, highlighted the median overall survival of 14.3 months and a 40% response rate in the DeLLphi-301 trial. Laurie Fenton Ambrose, CEO, co-founder, and president of GO2 for Lung Cancer, underscored the importance of this new targeted therapy after decades of minimal advancements in SCLC treatment. The phase 2 DeLLphi-301 trial demonstrated an objective response rate of 40% and a median duration of response of 9.7 months for patients treated with IMDELLTRA.

Reference: Amgen. FDA Approves Imdelltra™ (tarlatamab-dlle), the First and Only T-Cell Engager Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer. PR Newswire. Updated May 16, 2024. Accessed June 11, 2024. https://www.prnewswire.com/news-releases/fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-302148431.html