Brentuximab vedotin is approved by FDA in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

Brentuximab vedotin

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November 2022: The combination of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide with brentuximab vedotin (Adcetris, Seagen, Inc.) has been approved by the Food and Drug Administration for use in children and young adults with high-risk classical Hodgkin lymphoma who have not received treatment in the past (cHL). This is brentuximab vedotin’s first paediatric approval.

A randomised, open-label, actively controlled trial was used to assess effectiveness. Stage IIB with bulk illness in Ann Arbor, Stage IIIB, Stage IVA, and Stage IVB were all classified as high risk. Brentuximab vedotin plus doxorubicin (A), vincristine (V), etoposide (E), prednisone (P), and cyclophosphamide (C) [brentuximab vedotin + AVEPC] was given to 300 patients, while A+bleomycin (B)+V+E+P+C [ABVE-PC] was given to 300 patients. Each treatment arm’s patients could have had up to 5 cycles of the following:

Prednisone 20 mg/m2 BID (days 1-7), cyclophosphamide 600 mg/m2 (days 1 and 2), doxorubicin 25 mg/m2 (days 1 and 2), vincristine 1.4 mg/m2 (days 1 and 8), etoposide 125 mg/m2 (days 1-3), and brentuximab vedotin 1.8 mg/kg over 30 minutes (day (days 1 and 2).
Event-free survival (EFS), which is the time from randomization to the earliest of disease progression or recurrence, second malignancy, or death from any cause, served as the primary effectiveness outcome measure. In neither arm was the median EFS attained. With a comparable hazard ratio of 0.41 (95% CI: 0.25, 0.67; p=0.0002), there were 52 occurrences (17%) in the ABVE-PC arm and 23 events (8%) in the brentuximab vedotin + AVEPC arm.

In paediatric patients receiving brentuximab vedotin in combination with AVEPC, neutropenia, anaemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection were the most frequent Grade 3 adverse events (5%).

For children 2 years of age and older, the suggested brentuximab vedotin dose is 1.8 mg/kg up to 180 mg in conjunction with AVEPC every 3 weeks for a maximum of 5 doses.

View full prescribing information for Adcetris.

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