Amgen Receives FDA Approval for Imdelltra in Small Cell Lung Cancer

Amgen today announced that the FDA has granted accelerated approval to Imdelltra (tarlatamab-dlle) for adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Imdelltra is a bispecific T-cell engager (BiTE) that targets DLL3 on cancer cells and CD3 on T cells. In the DeLLphi-301 trial, Imdelltra demonstrated an overall response rate of 40% in patients who had received at least two prior lines of therapy. The median duration of response was 9.7 months. This approval provides a new treatment option for patients with this aggressive cancer type that has limited treatment options after platinum-based chemotherapy.