The FDA granted accelerated approval last week to brentuximab vedotin for use in patients with Hodgkin lymphoma (HL) which has relapsed after 2 prior therapies, and patients with anaplastic large T cell lymphoma (ALCL) which has relapsed after one prior treatment. Weill Cornell Medical College participated in the studies that led to the approval.
Brentuximab vedotin is an antibody-drug conjugate (ADC); that is, a chemotherapy drug which has been attached to a monoclonal antibody in order to deliver the drug more specifically to target cells. In this case, the ADC targets CD30, a protein on the surface of the malignant HL cells and ALCL. Two phase 2 clinical studies were recently completed evaluating activity of brentuximab vedotin in HL patients who had had recurrence following autologous stem cell transplant and in ALCL patients that had relapsed after prior therapy. Response in both patient groups was striking. In HL, 73% of patients responded to treatment, with 32% achieving complete remission. In ALCL, 86% of patients responded, with 57% achieving complete remission.
Major side effects of brentuximab vedotin in both groups of patients consisted of peripheral neuropathy, decreased blood counts, fatigue, nausea, rash and fever.
While long term results are still under investigation, initial response rates indicate that this drug represents an important new tool in the care of patients without other standard treatment options. Further studies are ongoing investigating how best to incorporate brentuximab vedotin into the routine care of patients with these lymphomas.