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Adcetris Approval History

  • FDA approved: Yes (First approved August 19th, 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 Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

Development History and FDA Approval Process for Adcetris

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

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