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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: brentuximab vedotin
Trade Name: Adcetris
Date Designated: 10/23/2008
Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Orphan Designation Status: Designated/Approved
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

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

Marketing approved:

1 Generic Name: brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 08/19/2011
Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
Exclusivity End Date: 08/19/2018 
Exclusivity Protected Indication* :  
2 Generic Name: brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 11/16/2018
Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
Exclusivity End Date: 11/16/2025 
Exclusivity Protected Indication* :  ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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