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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:
Date Designated: 06/05/2017
Orphan Designation: Treatment of breast cancer patients with brain metastases.
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:
Marketing Approval Date: 04/17/2020
Approved Labeled Indication: TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Exclusivity End Date: 04/17/2027 
Exclusivity Protected Indication* :  For use in combination with trastuzumab and capecitabine for treatment of adult patients with metastatic HER2-positive breast cancer and brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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