EU approves Amgen's IMDYLLTRA for advanced small-cell lung cancer, cutting death risk by 40%.

The European Commission has approved Amgen's IMDYLLTRA (tarlatamab) as a monotherapy for adults with advanced small-cell lung cancer (SCLC) after progression on platinum-based chemotherapy. This approval is based on the Phase 3 DeLLphi-304 trial showing a 40% reduction in death risk and a median overall survival improvement of over five months compared to standard chemotherapy. IMDYLLTRA is the first T-cell therapy approved for this aggressive cancer type, offering a new treatment option for patients with limited alternatives. Amgen continues to study IMDYLLTRA in various clinical trials to expand its use in earlier stages and combination therapies.