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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fam-trastuzumab deruxtecan-nxki
Trade Name: Enhertu
Date Designated: 05/20/2020
Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer
Orphan Designation Status: Designated/Approved
Daiichi Sankyo, Inc.
211 Mount Airy Road
Basking Ridge, New Jersey 07920
United States

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

Marketing approved:

1 Generic Name: fam-trastuzumab deruxtecan-nxki
Trade Name: Enhertu
Marketing Approval Date: 01/15/2021
Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
Exclusivity End Date: 01/15/2028 
Exclusivity Protected Indication* :  treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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