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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tucatinib
Trade Name: Tukysa
Date Designated: 09/18/2017
Orphan Designation: Treatment of HER2+ colorectal cancer
Orphan Designation Status: Designated/Approved
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tucatinib
Trade Name: Tukysa
Marketing Approval Date: 01/19/2023
Approved Labeled Indication: in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Exclusivity End Date: 01/19/2030 
Exclusivity Protected Indication* :  treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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