Amgen Inc. (AMGN) announced that the U.S. FDA has granted full approval to IMDELLTRA for adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Small-cell lung cancer is an aggressive malignancy, and treatment options after frontline therapy have historically been limited.
IMDELLTRA (tarlatamab-dlle), a bispecific T-cell engager (BiTE), was initially granted accelerated approval last May, and this conversion to full approval is based on results from the global Phase 3 DeLLphi-304 trial.
The study met its primary endpoint, showing that IMDELLTRA reduced the risk of death by 40% compared to standard chemotherapy. Median overall survival was extended by more than five months (13.6 months vs 8.3 months), with a hazard ratio of 0.60. These findings underscore IMDELLTRA as a new standard of care for patients with ES-SCLC who relapsed after platinum-based therapy.
Safety data from DeLLphi-304 were consistent with the drug's known profile. Grade 3 or higher adverse events occurred less frequently with IMDELLTRA (54%) than with chemotherapy (80%). The most common severe treatment-related events were neutropenia (4%) and lymphopenia (4%) for IMDELLTRA, versus anemia (28%) and neutropenia (22%) for chemotherapy.
Cytokine release syndrome was observed mainly after the first two doses, but cases were largely low grade, with no Grade 4 or 5 events reported. The label also carries warnings for neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), which can be life-threatening, requiring close monitoring and prompt intervention.
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to list tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC who progress after platinum-based chemotherapy. Amgen noted that it is also advancing IMDELLTRA into earlier stages of disease and earlier lines of therapy.
The drug generated $115 million in sales for the full year of 2024 and $178 million in sales for the third quarter of 2025, highlighting strong growth and increasing market adoption.
AMGN has traded in the range of $253.30 to $345.84 over the past year. The stock closed yesterday's trading at $342.40, down 0.46%.
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