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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: 01/30/2007
Orphan Designation: Treatment of Hodgkin's lymphoma
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 Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
Exclusivity End Date: 08/19/2018 
Exclusivity Protected Indication* :  
2 Generic Name: brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 08/17/2015
Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity End Date: 08/17/2022 
Exclusivity Protected Indication* :  Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
3 Generic Name: brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 03/20/2018
Approved Labeled Indication: ADCETRIS® is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity End Date: 03/20/2025 
Exclusivity Protected Indication* :  ADCETRIS® is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
4 Generic Name: brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 11/10/2022
Approved Labeled Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide
Exclusivity End Date: 11/10/2029 
Exclusivity Protected Indication* :  treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL)
*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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