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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 antibody drug conjugate (ADC) comprised of an anti-B cell maturation (BCMA) IgG1 humanized antibody conjugated covalently to the dibenzocyclooctyne (DBCO) noncleavable linker maytansinoid warhead.
Date Designated: 02/23/2021
Orphan Designation: Treatment of multiple myeloma (MM)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/09/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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