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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: THIOMAB antibody drug conjugate comprised of humanized IgG1 anti-C-type lectin-like molecule-1 monoclonal antibody and DNA alkylating cross-linking agent pyrrolo [2,1-c][1,4] benzodiazepine dimer
Date Designated: 10/24/2017
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 12/08/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Genentech, Inc.
1 DNA Way
mail stop: B-35, 355d
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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