Amgen Receives Full FDA Approval for Imdelltra in Extensive-Stage 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 who have progressed on or after platinum-based chemotherapy. The full approval was based on overall survival data from the Phase 3 DeLLphi-304 trial demonstrating a statistically significant improvement in OS versus topotecan. This full approval establishes Imdelltra as a standard treatment option for relapsed SCLC and represents a significant advancement in this difficult-to-treat cancer.