European Commission approves IMDYLLTRA for small cell lung cancer after platinum therapy

The European Commission granted marketing authorization for IMDYLLTRA (tarlatamab) as monotherapy for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. The approval rests on the Phase 3 DeLLphi-304 trial, which showed median overall survival of 13.6 months versus 8.3 months on chemotherapy. It opens a second major market for a drug that is already one of Amgen's fastest-growing oncology products.

• Authorization covers adults with ES-SCLC progressing on or after first-line platinum chemotherapy
• DeLLphi-304 median overall survival 13.6 months vs 8.3 months with chemotherapy
• Reduced the risk of death by 40%
• Extended median overall survival by more than five months