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Adcetris FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved August 19, 2011)
Brand name: Adcetris
Generic name: brentuximab vedotin
Dosage form: Injection
Company: Seattle Genetics, Inc.
Treatment for: Lymphoma, Hodgkin's Lymphoma, Mycosis Fungoides

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of adult patients with:

  • Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
  • Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
  • Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
  • Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
  • Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
  • Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy.

Development Timeline for Adcetris

Nov 16, 2018Approval  FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
Mar 20, 2018Approval  FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy
Nov  9, 2017Approval  Seattle Genetics Announces FDA Approval of Adcetris (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)
Jan 13, 2012Approval  Seattle Genetics Announces Updates to Adcetris Prescribing Information
Aug 19, 2011Approval  FDA Approves Adcetris to Treat Two Types of Lymphoma
Jul 15, 2011Seattle Genetics Announces Unanimous Recommendations from FDA Advisory Committee in Favor of Accelerated Approval of Adcetris for Post-Transplant Relapsed Hodgkin Lymphoma and Relapsed or Refractory Systemic ALCL
Jun 20, 2011Seattle Genetics Announces FDA Advisory Committee to Review Brentuximab Vedotin for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
May  2, 2011Seattle Genetics Announces FDA Accepts Brentuximab Vedotin BLAs for Filing and Grants Priority Review for Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
Feb 28, 2011Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.