Brentuximab vedotin combination therapy receives FDA approval for high-risk cHL in patients aged ≥2 years

On November 10, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to brentuximab vedotin plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC) for the treatment of pediatric patients aged ≥2-years with previously untreated high-risk classical Hodgkin lymphoma.¹

The approval is based on key data obtained from the phase III AHOD1331 clinical trial (NCT02166463) of brentuximab vedotin plus AVE-PC in children and young adults. In the trial, patients who received combination therapy had significantly improved event-free survival compared to those who received standard of care treatment. These patients also experienced a 59% reduction in the risk of disease progression or relapse, second cancer, or death.