INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) announced that the FDA has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation. The designation is based on preliminary results from the open-label, multicenter, Phase 1/2 LOXO-RAS-20001 study of olomorasib.
Olomorasib was previously granted Breakthrough Therapy designation, in combination with anti-PD-1 therapy KEYTRUDA, for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression - 50%.
In pre-market trading on NYSE, Eli Lilly shares are up 1.37 percent to $1,164.24.
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