> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Lilly Gets Orphan Status for Pancreatic Cancer Drug
- URL: https://www.fdaweb.com/lilly-gets-orphan-status-for-pancreatic-cancer-drug/
- Published: 2026-10-05T16:01:00.000Z
- Updated: 2026-10-06T00:12:18.000Z
- Author: David McFarland
- Tags: Drugs

FDA has granted Eli Lilly an [orphan drug designation](http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1151826.&ref=fdaweb.com) for olomorasib as a monotherapy for 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.