The FDA expedited the approval of brentuximab vedotin (Adcetris, Seattle Genetics) for the treatment of Hodgkin lymphoma, as well as for systemic anaplastic large-cell lymphoma (ALCL), a rare non-Hodgkin lymphoma that may manifest in several parts of the body, including the lymph nodes, skin, bones, soft tissue, lungs, and liver. Brentuximab is the first CD30-directed antibody-drug conjugate approved for systemic ALCL; it is also the first treatment ever approved for this rare disease.
Brentuximab is indicated for patients with Hodgkin lymphoma that has progressed after autologous stemcell transplantation (ASCT) or after 2 previous chemotherapy treatments. Brentuximab is also indicated for patients with systemic ALCL whose disease has progressed after 1 previous chemotherapy treatment.
“Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” said Dr Pazdur.
The approval for Hodgkin lymphoma was based on a single-arm trial involving 102 patients, who had an objective response rate to the drug of 73%, with 32% of patients showing complete remission and 40% showing partial remission; the median response duration was 6.7 months.
The approval for systemic ALCL was based on a single-arm clinical trial in 58 patients; treatment with brentuximab showed 86% objective response: 57% complete remission and 29% partial remission. The median objective response duration was 12.6 months.
The recommended dosage is a 1.8- mg/kg intravenous infusion administered over 30 minutes every 3 weeks. Treatment may continue up to 16 cycles or until disease progression or unacceptable toxicity occurs.
The most common adverse effects associated with this drug include neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia. (August 19, 2011)
