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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a lentivirally transduced autologous AML vaccine expressing CD80, IL-15, and IL-15Ralpha
Date Designated: 01/13/2026
Orphan Designation: treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
University of California, San Francisco
513 Parnassus Avenue
Room S770
San Francisco, California 94143
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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