The US Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) for the treatment of pediatric patients 2 years of age and older with previously untreated, high-risk classical Hodgkin lymphoma.

Brentuximab vedotin is approved for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for this patient group.

The approval was based on data from the open-label, phase 3 AHOD1331 trial (ClinicalTrials.gov Identifier:  NCT02166463). The study was designed to compare brentuximab vedotin plus chemotherapy to chemotherapy alone in patients (aged 2-21 years) with previously untreated Hodgkin lymphoma (stages IIB plus bulk, IIIB, IVA, or IVB).


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Patients were randomly assigned to 5 cycles of brentuximab vedotin plus AVEPC (n=300) or doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide (ABVE-PC; n=300).

Treatment with brentuximab vedotin plus AVEPC reduced the risk of disease progression or relapse, second malignancy, or death (primary endpoint) by 59% when compared with ABVE-PC (hazard ratio, 0.41; 95% CI, 0.25-0.67; P =.0002).

The most common grade 3 or higher adverse reactions with brentuximab vedotin plus AVEPC were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.

References

  1. Seagen announces US FDA approval of new indication for Adectris® (brentuximab vedotin) for children with previously untreated high risk Hodgkin lymphoma. News release. November 10, 2022. https://www.businesswire.com/news/home/20221108006332/en/Seagen-Announces-U.S.-FDA-Approval-of-New-Indication-for-ADCETRIS%C2%AE-brentuximab-vedotin-for-Children-with-Previously-Untreated-High-Risk-Hodgkin-Lymphoma
  2. Adcetris. Package insert. Seagen, Inc.; 2022. Accessed November 10, 2022. https://seagendocs.com/Adcetris_Full_Ltr_Master.pdf

This article originally appeared on MPR