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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Antibody-drug conjugate (ADC) comprising an anti-ROR1 monoclonal antibody (UC-961), a proteolytically cleavable maleimidocaproyl-valine-citrulline-para-aminobenzoate linker (mc-vc-PAB), and a monomethyl auristatin E (MMAE) cytotoxin.
Date Designated: 08/26/2020
Orphan Designation: Treatment of mantle cell lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Merck Sharp & Dohme, LLC
126 East Lincoln Ave.
P.O. Box 2000
Rahway, New Jersey 07065
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.