Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with KEYTRUDA (pembrolizumab), for first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation and high PD-L1 expression.
Olomorasib is a potent, selective second-generation inhibitor targeting the KRAS G12C mutation, with early evidence suggesting activity against central nervous system (CNS) metastases. The Breakthrough Therapy designation is designed to accelerate the development and review of drugs that may offer substantial improvements over existing therapies for serious conditions.
David Hyman, M.D., Lilly’s chief medical officer, emphasized the significance of the designation, noting the urgent need for better treatment options for KRAS G12C-mutant NSCLC patients, especially in combination with immunotherapy in the first-line setting.
The FDA’s decision follows promising results from the Phase 1/2 LOXO-RAS-20001 trial and dose optimization data from the ongoing Phase 3 SUNRAY-01 trial. Lilly plans to share updated findings from these studies at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona, scheduled for September 6-9.
This designation marks a key milestone for olomorasib, as Lilly continues to explore its potential in combination with immunotherapies across various treatment settings in ongoing Phase 3 trials SUNRAY-01 and SUNRAY-02.