Eli Lilly (LLY) announced that the FDA has granted Breakthrough Therapy designation to olomorasib, in combination with anti-PD-1 therapy Keytruda, 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 greater than or equal to 50%, as determined by FDA approved tests. Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system activity.
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