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# Lilly Gets Breakthrough Status for Pancreatic Cancer Therapy
- URL: https://www.fdaweb.com/lilly-gets-breakthrough-status-for-pancreatic-cancer-therapy/
- Published: 2026-08-03T12:00:00.000Z
- Updated: 2026-09-14T13:44:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161565

FDA has granted Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for the treating adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is described as an investigational, potent and highly selective next-generation inhibitor of KRAS G12C, and was [previously granted](https://investor.lilly.com/news-releases/news-release-details/lillys-olomorasib-receives-us-fdas-breakthrough-therapy?ref=fdaweb.com) a breakthrough therapy designation, in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab), 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 greater than 50%, as determined by FDA approved tests.

[Lilly says](https://sg.finance.yahoo.com/news/lillys-olomorasib-receives-u-fdas-114500022.html?ref=fdaweb.com) the new breakthrough status was based on “encouraging preliminary results from the open-label, multicenter, Phase 1/2 LOXO-RAS-20001 study ([NCT04956640](https://clinicaltrials.gov/study/NCT04956640?ref=fdaweb.com)) of olomorasib in patients with KRAS G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.”