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Drug - Adcetris (brentuximab vedotin) [Seattle Genetics, Inc]

February 2012

Therapeutic area - Oncology

Approval criteria

  • Hodgkin lymphoma (HL) diagnoses AND
  • Failure of autologous stem cell transplant (ASCT) or failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates OR
  • Systemic anaplastic large cell lymphoma (ALCL) diagnoses AND
  • Failure of at least one prior multi-agent chemotherapy regimen 

Quantity limit

180 mg every 3 weeks; 4 vials should provide a quantity sufficient for a 1 month supply.

Background information

The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks. The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.

ADCETRIS (brentuximab vedotin, formerly known as SGN-35) is the first approved antibody-drug conjugate (ADC) directed to CD30-expressing cells.  ADCETRIS was studied as monotherapy in 160 patients in two pivotal phase 2 trials. Assessment of efficacy included objective response rate (complete remission plus partial remission) and duration of response.

The indications for ADCETRIS are based on response rate. There is no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

NCCN Guidelines for Hodgkins Lymphoma recommended Adcetris as an option for patient with progressive disease after HDT/ASCR or at least two prior chemotherapy regimens for all patients regardless of their eligibility for HDT/ASCR.


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