Posted by Michael Wonder on 04 Sep 2025
Lilly's olomorasib receives US FDA's breakthrough therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
4 September 2025 - The breakthrough therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial.
Eli Lilly today announced that the US FDA has granted breakthrough therapy designation to olomorasib, in combination with pembrolizumab for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.
