On November 10, 2022, the FDA approved #brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical #Hodgkin lymphoma (cHL).

The approval was based on randomized, phase III AHOD1331 study, which 600 patients with high risk (Ann Arbor Stage IIB with bulk disease, Stage IIIB, Stage IVA, and Stage IVB) were randomized (1:1) to brentuximab vedotin plus doxorubicin, vincristine, etoposide , prednisone, and cyclophosphamide [brentuximab vedotin + AVEPC] Vs doxorubicin +bleomycin+ vincristine+ etoposide+ prednisone + cyclophosphamide [ABVE-PC].

There were 23 events (8%) in the brentuximab vedotin + AVEPC arm and 52 events (17%) in the ABVE-PC arm with a corresponding hazard ratio of 0.41 (95% CI: 0.25, 0.67; p=0.0002).