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news.Eli Lilly has received the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to olomorasib, an investigational KRAS G12C inhibitor.
The designation applies when olomorasib is used in combination with pembrolizumab for non-small cell lung cancer. Credit: Robina Weermeijer on Unsplash.
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This designation applies when olomorasib is used in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the initial treatment of unresectable advanced or metastatic non-small cell lung cancer (NSCLC) that features a KRAS G12C mutation and a PD-L1 expression of at least 50%, as recognised by FDA-approved tests.
Olomorasib is a second-generation, selective inhibitor that has shown preliminary evidence of activity in the central nervous system.
The designation aims to speed up the development and evaluation of drugs that show significant improvement over existing treatments for serious conditions.
It is based on promising clinical data, including findings from the Phase I/II LOXO-RAS-20001 trial and the dose optimisation segment of the Phase III SUNRAY-01 study.
Lilly chief medical officer David Hyman said: “The breakthrough therapy designation recognises the potential for olomorasib to be a meaningful treatment advance and highlights the continued unmet need for improved options for patients with KRAS G12C-mutant NSCLC, particularly in the first-line setting in combination with standard-of-care immunotherapy.
“We look forward to presenting updated data from the olomorasib development programme in significantly more patients and with longer follow-up at WCLC and continuing to investigate olomorasib in combination with immunotherapy-based regimens in a variety of treatment settings across the Phase III SUNRAY-01 and SUNRAY-02 studies.”
Revised findings from a comprehensive analysis of these studies will be showcased at the 2025 World Conference on Lung Cancer (WCLC), organised by the International Association for the Study of Lung Cancer (IASLC), which is set to take place from 6–9 September in Spain.
