Amgen says FDA grants full approval to IMDELLTRA

Amgen (AMGN) announced that the U.S. FDA has granted full approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA’s prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were recently updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.