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# FDA Says Lilly’s Olomorasib is Breakthrough Therapy
- URL: https://www.fdaweb.com/fda-says-lillys-olomorasib-is-breakthrough-therapy/
- Published: 2025-09-04T12:00:00.000Z
- Updated: 2026-09-14T15:20:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159813

FDA has granted breakthrough therapy designation to Lilly’s olomorasib in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) 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 at or under 50% as determined by FDA-approved tests. A Lilly [statement](https://investor.lilly.com/news-releases/news-release-details/lillys-olomorasib-receives-us-fdas-breakthrough-therapy?ref=fdaweb.com) describes olomorasib as an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. It is said to be a highly potent covalent inhibitor with potential for greater than 90% target occupancy, which may allow for safer combinations with less toxicity.