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FDA Approval of Brentuximab Vedotin for Pediatric High-Risk Classical Hodgkin Lymphoma
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.
Clinical Trial Efficacy and Event-Free Survival Outcomes
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.
Common Adverse Events and Recommended Dosage for Pediatric Patients
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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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.