FDA Approves Brentuximab Vedotin for Pediatric High-Risk Hodgkin Lymphoma

The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin for the treatment of pediatric patients two years and older with previously untreated high-risk classical Hodgkin lymphoma, in combination with standard-of-care, dose-intensive chemotherapy consisting of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC).

The approval is based on data from a phase III study conducted by the Children’s Oncology Group and funded by the National Cancer Institute that showed patients receiving brentuximab vedotin in combination with standard-of-care, dose-intensive chemotherapy AVE-PC had superior event-free survival compared with patients who received standard-of-care chemotherapy doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Patients had a 59% reduction in the risk of disease progression or relapse, second cancer, or death (hazard ratio 0.41; 95% CI, 0.25-0.67; P=.0002).

This FDA approval marks a new indication for the drug, which is already approved in adult patients with certain lymphomas.

Source: BusinessWire, November 2022