The Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

The approval was based on data from the open-label phase 3 AHOD1331 trial (ClinicalTrials.gov Identifier:  NCT02166463). The study compared brentuximab vedotin, a CD30-directed antibody-drug conjugate, in combination with chemotherapy with standard of care chemotherapy alone, in patients 2 to less than 22 years of age with previously untreated Hodgkin lymphoma stages IIB + bulk, IIIB, IVA or IVB.

Patients were randomly assigned to 5 cycles of brentuximab vedotin + doxorubicin (A), vincristine (V), etoposide (E), prednisone (P), cyclophosphamide (C) (n=300) or A + bleomycin (B) + V+ E+P+C (ABVE-PC; n=300).

Results showed treatment with brentuximab vedotin + 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 greater adverse reactions in pediatric patients treated with brentuximab vedotin in combination with AVEPC were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.

“We are excited about the approval of Adcetris for children and adolescents with high risk classical Hodgkin lymphoma because this medicine, which has become part of standard of care for adults with previously untreated advanced stage Hodgkin lymphoma, will now be accessible to young patients as well,” said Sharon M. Castellino, MD, MSc, Professor, Department of Pediatrics, Emory University School of Medicine, AHOD1331 Study Chair and COG Hodgkin Lymphoma Disease Committee Chair.

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