FDA Breakthrough Status Awarded To Lilly-Merck Combo Drug For Advanced Non-Small Cell Lung Cancer

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The U.S. Food and Drug Administration (FDA) on Thursday granted Breakthrough Therapy designation to Eli Lilly and Co.’s (NYSE:LLY) olomorasib, in combination with Merck & Co. Inc.’s (NYSE:MRK) anti-PD-1 therapy Keytruda (pembrolizumab), for the first-line treatment of unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%.

Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system (CNS) activity.