Brentuximab Vedotin Approved by FDA for Children With Previously Untreated High-Risk Hodgkin Lymphoma


FDA approves brentuximab vedotin for the treatment of patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

The FDA has approved brentuximab vedotin (Adcetris) for the treatment of pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma, as a combination therapy with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC).

The decision was based on data from the phase 3 AHOD1331 trial, which was conducted by the Children's Oncology Group and sponsored by the National Cancer Institute. The trial found that the addition of brentuximab vedotin significantly improved event-free survival (EFS) compared with standard-of-care treatment with doxorubicin, belomycin, vincristine, etoposide, prednisone, and cyclophosphamide (ABVE-PC) in patients with classical Hodgkin lymphoma.

Patients administered brentuximab vedotin experienced a decrease in the risk of disease progression or relapse, second cancer, or death by 59% (HR, 0.41; 95% CI, 0.25-0.67; = .0002).

“[Brentuximab vedotin] is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical Hodgkin lymphoma,” said Marjorie Green, MD, senior vice president and head of late-stage development at Seagen Inc, in a press release. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval.”

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprised of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

AHOD1331 is the largest multicenter, randomized, open-label, phase 3 trial conducted in pediatric patients with newly diagnosed, high-risk Hodgkin lymphoma. The trial enrolled 587 patients aged from 2 to 21 years. To be eligible, patients were required to have previously untreated Hodgkin lymphoma with stage IIB and bulky disease, stage IIIB disease, stage IVA disease, or stage IVB disease.

Participants were randomized to receive 5 cycles of either standard dose-intensive chemotherapy ABVE-PC or brentuximab vedotin plus AVE-PC administered every 21 days with granulocyte colony-stimulating factor support. EFS was the primary objective of the research.

“We are excited about the approval of [brentuximab vedotin] 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,” Sharon M. Castellino, MD, MSc, professor, Department of Pediatrics, Emory University School of Medicine, AHOD1331 study chair and COG Hodgkin Lymphoma Disease Committee chair, said in a press release.


Seagen Announces U.S. FDA Approval of New Indication for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma. Seagen. News release. November 10, 2022. Accessed November 10, 2022.

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