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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
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.
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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