Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
“The FDA approval of brentuximab vedotin for post-autologous hematopoietic transplantation consolidation treatment in classical Hodgkin lymphoma patients with high risk of relapse or progression is a significant milestone for patients and physicians,” said Craig Moskowitz, MD, lead investigator on the trial and clinical director, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, in New York, NY.
“Approximately half of all Hodgkin lymphoma patients who undergo an autologous hematopoietic stem cell transplant will relapse, representing a significant need for additional treatment options to improve progression-free survival.”
The approval is based on the phase 3 AETHERA clinical trial, which found that brentuximab vedotin following auto-HSCT improved median progression-free survival by 18.8 months over placebo.
Patients with classical HL at high risk of relapse or progression receiving brentuximab vedotin as post-auto-HSCT should receive it within 4 to 6 weeks of auto-HSCT or upon recovery from auto-HSCT.
Brentuximab vedotin should be administered at a dose of 1.8 mg/kg intravenously over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.
In regard to safety, brentuximab vedotin carries a boxed warning alerting healthcare professionals to the increased risk of progressive multifocal leukoencephalopathy (PML) and death caused by the JC virus.
Common adverse events in patients receiving brentuximab vedotin as post-auto-HSCT consolidation include neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea.
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Brentuximab vedotin is a CD30-directed antibody-drug conjugate also indicated for the treatment of patients with classical HL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who not auto-HSCT candidates, and for those with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
- Seattle Genetics Announces FDA Regular Approval of ADCETRIS® (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation [news release]. Seattle, WA: Seattle Genetics, Inc; August 17, 2015. http://investor.seattlegenetics.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2080061. Accessed August 17, 2015.