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# Orphan Status for Cascadian Colorectal Cancer Therapy
- URL: https://www.fdaweb.com/orphan-status-for-cascadian-colorectal-cancer-therapy/
- Published: 2017-09-27T12:00:00.000Z
- Updated: 2026-09-14T22:52:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139724

FDA has granted Cascadian Therapeutics an orphan drug designation to tucatinib for treating HER2-positive (HER2+) metastatic colorectal cancer. Tucatinib is an investigational oral, small molecule kinase inhibitor that the company says is highly selective for HER2\. Cascadian is currently sponsoring an investigator-initiated Phase 2 study (MOUNTAINEER) evaluating tucatinib in the target patient population. The orphan status was granted based on *in vitro* and non-clinical HER2+ colorectal tumor models, it says.