FDA Approves IMDELLTRA® as Standard Therapy for Small Cell Lung Cancer
FDA Grants Full Approval to AMGEN's IMDELLTRA®
On November 19, 2025, the U.S. Food and Drug Administration (FDA) granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adults with extensive stage small cell lung cancer (ES-SCLC). This approval marks a pivotal moment for patients whose cancer has progressed after using platinum-based chemotherapy. It transforms IMDELLTRA from accelerated to full approval status based on promising data from the global Phase 3 DeLLphi-304 study.
The DeLLphi-304 trial provided substantial evidence demonstrating that patients receiving IMDELLTRA experienced a 40% reduction in the risk of death compared to those undergoing standard chemotherapy. Furthermore, patients treated with IMDELLTRA exhibited a median overall survival increase of over five months—a significant advancement considering the aggressive nature of ES-SCLC. While standard chemotherapy yielded a median overall survival of 8.3 months, those on IMDELLTRA enjoyed a median of 13.6 months.
Dr. Jay Bradner from Amgen emphasized how this approval solidifies IMDELLTRA as a standard treatment for ES-SCLC patients whose cancer has worsened after frontline therapy.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.