FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma

In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death

The FDA has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high-risk classical Hodgkin lymphoma (cHL). It is approved to be used in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

Hodgkin lymphoma is blood cancer of the lymphocytes. Classic Hodgkin lymphoma (cHL) accounts for more than 9 in 10 cases of Hodgkin lymphoma in developed countries, according to the American Cancer Society. About one-third of all Hodgkin lymphoma patients are classified as high risk.

Adcetris, jointly developed by Seagen and Takeda, is a CD30 directed antibody-drug conjugate. It is currently available for several indications, including adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine, and dacarbazine, cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation, adult patients systemic anaplastic large cell lymphoma, and Adult patients with primary cutaneous anaplastic large cell lymphoma.

“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,” Sharon M. Castellino, M.D., professor, pepartment of Pediatrics, Emory University School of Medicine, study chair and chair of Children’s Oncology Group Hodgkin Lymphoma Disease Committee.

The approval is based on data from a phase 3 study showed that patients who received Adcetris plus standard of care chemotherapy experienced a 59% deduction in risk of disease progression or relapse, second malignancy or death vs. standard of care alone. The study was conducted by the Children’s Oncology Group (COG) and funded by the National Cancer Institute.

In the study, 600 pediatric and young adult patients were randomized to either Adcetris plus [Adriamycin (doxorubicin), bleomycin, vincristine, etoposide, prednisone and cyclophosphamide] or the standard chemotherapy alone. At median follow-up of 42.1 months, three-year event-free survival rate in the Adcetris arm was 92.1% compared with 82.5% in the control arm. The treatment regimen was well-tolerated. Grade 3+ adverse events recorded, including febrile neutropenia, were comparable across both arms and consistent with the known dose-intensive chemotherapy regimen. Grade 2+ peripheral neuropathy rates were similar across both arms. No deaths occurred during treatment.

The wholesale acquisition cost (WAC) for Adcetros is $10,078.00 per 50-mg vial as of July 2022, according to the company