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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: belantamab mafodotin-blmf
Trade Name: BLENREP
Date Designated: 06/22/2017
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
GlaxoSmithKline Intellectual Property Development Ltd.
980 GREAT WEST ROAD
BRENTFORD, MIDDLESEX TW89GS
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: belantamab mafodotin-blmf
Trade Name: BLENREP
Marketing Approval Date: 08/05/2020
Approved Labeled Indication: for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent (indication withdrawn)
Exclusivity End Date: 02/06/2023 
Exclusivity Protected Indication* :  for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent (indication withdrawn)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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