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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tebentafusp-tebn
Trade Name: Kimmtrak
Date Designated: 01/21/2016
Orphan Designation: Treatment of uveal melanoma
Orphan Designation Status: Designated/Approved
Immunocore Ltd
Milton Park
90 Park Drive
Milton
United Kingdom

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

Marketing approved:

1 Generic Name: tebentafusp-tebn
Trade Name: Kimmtrak
Marketing Approval Date: 01/25/2022
Approved Labeled Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
Exclusivity End Date: 01/25/2029 
Exclusivity Protected Indication* :  treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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