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Eli Lilly's Lung Cancer Drug Candidate Gets FDA Breakthrough Therapy Designation
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Eli Lilly's Lung Cancer Drug Candidate Gets FDA Breakthrough Therapy Designation
Sep 4, 2025 4:37 AM

07:15 AM EDT, 09/04/2025 (MT Newswires) -- Eli Lilly ( LLY ) said Thursday its olomorasib inhibitor, in combination with Merck's ( MRK ) Keytruda, has received breakthrough therapy designation from the US Food and Drug Administration to treat certain metastatic KRAS G12C-mutant lung cancers.

The designation from the FDA is based on strong results from a phase 1/2 trial and the dose optimization portion of a phase 3 trial, the company said.

Olomorasib is a second-generation KRAS G12C inhibitor aimed at non-small cell lung cancer, the company said.

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