Skip to main content

Adcetris FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 15, 2022.

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) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and mycosis fungoides.

  • Adcetris is 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.
    • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.
    • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
    • Adult patients with 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.
    • Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral Tcell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
    • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
    • Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. 
  • Adcetris is administered as an intravenous infusion over 30 minutes.
  • Warnings and precautions associated with Adcetris include peripheral neuropathy, anaphylaxis and infusion reactions, hematologic toxicities, serious infections and opportunistic infections, tumor lysis syndrome, hepatotoxicity, pulmonary toxicity, serious dermatologic reactions, gastrointestinal complications, hyperglycemia, and embryo-fetal toxicity.
  • Common adverse reactions include peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

Development timeline for Adcetris

Nov 10, 2022Approval Seagen Announces U.S. FDA Approval of New Indication for Adcetris (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma
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.