European Commission Approves Amgen's IMDYLLTRA® for Lung Cancer Treatment

Amgen has secured marketing authorization from the European Commission for its drug IMDYLLTRA® (tarlatamab) aimed at treating extensive-stage small cell lung cancer (ES-SCLC) in adults requiring systemic therapy after initial platinum-based chemotherapy. This approval follows the Phase 3 DeLLphi-304 trial, which highlighted a 40% reduction in death risk compared to chemotherapy, extending median overall survival from 8.3 to 13.6 months.

Jean-Charles Soria from Amgen acknowledges small cell lung cancer's aggressive nature and limited treatment options, noting the significance of this approval as the first T-cell engager therapy for such the condition. The safety profile remained consistent, with common adverse reactions including cytokine release syndrome and decreased appetite.

The DeLLphi-304 trial involved 509 patients comparing IMDYLLTRA and standard chemotherapy across various countries. With these promising results, IMDYLLTRA represents a significant advancement for treatment-resistant ES-SCLC patients.