Amgen Receives Full FDA Approval for Imdelltra in Small Cell Lung Cancer

Amgen today announced that the FDA has converted the accelerated approval of Imdelltra (tarlatamab-dlle) to full approval for the treatment of adults with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The conversion was based on overall survival data from the Phase 3 DeLLphi-L301 trial demonstrating a statistically significant improvement in OS. The median OS was 14.3 months for tarlatamab versus 8.9 months for chemotherapy. This full approval reinforces Imdelltra as a standard treatment option in relapsed SCLC.