Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full regulatory approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.
This decision converts the drug’s prior accelerated approval into a full approval, establishing IMDELLTRA as a recognized standard of care for a patient population with historically limited treatment options. The therapy is also now recognized by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as the only Category 1 preferred treatment option in this setting.
Landmark Phase 3 Data Drives Full Approval
The full approval is based on compelling overall survival data from the global Phase 3 DeLLphi-304 study. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for patients treated with IMDELLTRA compared to standard of care (SOC) chemotherapy.
Key efficacy findings from the trial include:
- 40% Reduction in Risk of Death: IMDELLTRA reduced the risk of death by 40% compared to SOC chemotherapy.
- Extended Overall Survival: Median overall survival (OS) was significantly extended by more than five months in the IMDELLTRA arm (13.6 months) versus the chemotherapy arm (8.3 months). (Hazard Ratio [HR], 0.60; 95% CI: 0.47, 0.77; P < 0.001).
Read More: Amgen’s IMDELLTRA® Phase 3 Trials Demonstrated Superior Overall Survival in Small Cell Lung Cancer
The FDA’s decision reinforces IMDELLTRA as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy,
We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing IMDELLTRA in earlier stages of disease and earlier lines of therapy.
Jay Bradner
A New Hope for a Devastating Disease
Small Cell Lung Cancer (SCLC) is one of the most aggressive and devastating forms of solid tumor cancers, accounting for 13-15% of all lung cancer cases. While patients often initially respond well to platinum-based chemotherapy, most quickly relapse within months, highlighting the critical need for effective subsequent treatment options. The five-year relative survival rate for SCLC is tragically low, at 5-10% across all stages combined.
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Drug Mechanism and Safety Profile
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers. It functions as a bispecific T-cell engager that simultaneously binds to DLL3 (Delta-like ligand 3), a protein highly expressed on SCLC tumor cells, and CD3 on the patient’s own T cells. This binding activates the T cells, redirecting them to kill the DLL3-expressing cancer cells.
The safety profile of IMDELLTRA in the DeLLphi-304 study was consistent with its known profile. The trial showed fewer Grade 3 or greater adverse events in the IMDELLTRA arm compared to the chemotherapy arm (54% vs 80%).
Cytokine Release Syndrome (CRS), a serious potential side effect associated with T-cell engaging therapies, occurred in some patients, primarily after the first two doses, but was mostly low grade (42% Grade 1; 13% Grade 2; 1% Grade 3). No Grade 4 or Grade 5 CRS events were reported. The drug also carries a Boxed Warning for the risk of CRS and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
