Eli Lilly: FDA Grants Breakthrough Therapy Designation To Olomorasib

(RTTNews) - Eli Lilly and Company (LLY) announced 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 = 50%, as determined by FDA approved tests. The designation is based on results from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial.

David Hyman, chief medical officer, said: "We look forward to presenting updated data from the olomorasib development program in significantly more patients and with longer follow-up at WCLC and continuing to investigate olomorasib in combination with immunotherapy-based regimens in a variety of treatment settings across the Phase 3 SUNRAY-01 and SUNRAY-02 studies."

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