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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: retifanlimab-dlwr
Trade Name: Zynyz
Date Designated: 03/24/2020
Orphan Designation: Treatment of anal cancer
Orphan Designation Status: Designated/Approved
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

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

Marketing approved:

1 Generic Name: retifanlimab-dlwr
Trade Name: Zynyz
Marketing Approval Date: 05/15/2025
Approved Labeled Indication: in combination with carboplatin and paclitaxel, for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC); and as a single agent, for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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