FDA Grants Breakthrough Designation for KRAS G12C Lung Cancer Treatment
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to olomorasib, used in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the first-line treatment of adults with unresectable, advanced, or metastatic non-small cell lung cancer (NSCLC) carrying a KRAS G12C mutation and PD-L1 expression of 50% or higher, as determined by FDA-approved tests.
Olomorasib is a highly selective, second-generation inhibitor of KRAS G12C and has shown preliminary activity in the central nervous system (CNS).
Breakthrough Therapy Designation is designed to accelerate the development and review of treatments for serious conditions, particularly when early clinical data indicate a drug may offer significant improvement over existing therapies.
The designation is based on promising results from the Phase 1/2 LOXO-RAS-20001 trial and the dose-optimization phase of the Phase 3 SUNRAY-01 trial.
