FDA approves Adcetris with chemotherapy for children with high-risk Hodgkin lymphoma
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The FDA approved brentuximab vedotin in combination with chemotherapy for treatment of certain children with Hodgkin lymphoma, according to the agent’s manufacturer.
Brentuximab vedotin (Adcetris, Seagen) is an antibody-drug conjugate directed at CD30. The agent is approved in the United States for treatment of several subgroups of patients with lymphoma.
The new indication applies to use of brentuximab vedotin with chemotherapy by pediatric patients aged 2 years or older with previously untreated high-risk classical Hodgkin lymphoma.
The FDA based the approval on results of the randomized phase 3 AHOD1331 study, which enrolled 587 patients aged 2 to 21 years. All patients had previously untreated stage IIB to stage IVB Hodgkin lymphoma.
Investigators randomly assigned patients to five cycles of standard dose-intensive chemotherapy with doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide, or to brentuximab vedotin plus chemotherapy with vincristine, etoposide, prednisone and cyclophosphamide.
EFS served as the primary endpoint.
Results showed a 59% reduction in risk for progression, relapse, second cancer or death among patients assigned brentuximab vedotin (HR = 0.41; 95% CI, 0.25-0.67).
“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, MD, MSc, professor in the department of pediatrics at Emory University School of Medicine and AHOD1331 study chair, said in a Seagen-issued press release.
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