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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous genetically engineered T cells that express a single-domain antibody that recognizes human mesothelin fused to the cluster of differentiation 3e subunit of the T cell receptor
Date Designated: 02/01/2019
Orphan Designation: Treatment of mesothelioma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/16/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TCR2 Therapeutics, Inc., a wholly owned subsidiary of Adaptimmune Therapeutics plc
100 Binney Street
Suite 710
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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