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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an adoptive cellular therapy (ACT) based on the use of autologous T cells engineered ex vivo to express a T cell receptor (TCR) specific to the preferentially expressed antigen in melanoma (PRAME)-004 target peptide presented by HLA-A*02:01
Date Designated: 02/03/2026
Orphan Designation: treatment of Stage II and higher cutaneous melanoma (CM), in human leukocyte antigen (HLA)-A*02:01-positive patients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Immatics US, Inc
13203 Murphy Rd
Stafford, Texas 77477
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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