FDA has granted approval to antibody conjugate (ADC), brentuximab vedotin (Adcetris) plus AVE-PC (doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide) for children aged 2 years or older with previously untreated, high-risk classical Hodgkin lymphoma.
Brentuximab vedotin is an ADC that has been approved for adults with certain types of adults. Its FDA approval is based on the findings of phase III AHOD1331 trial.
The open-label, multicenter, randomised AHOD1331 phase III study enrolled 587 patients (age 2 to 21 years) with newly diagnosed, high-risk Hodgkin lymphoma. The participants were randomly assigned to receive either brentuximab vedotin plus AVE-PC or the standard dose-intensive chemotherapy ABVE-PC (doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide). The primary objective of the research was event-free survival (EFS).
Adding ADC to AVE-PC significantly improved EFS than those treated with standard-of-care ABVE-PC. Furthermore, treatment in the ADC arm significantly reduced the risk of disease progression or relapse, second cancer, or death by 59% (HR, 0.41; 95% CI, 0.25-0.67; P = .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,” Marjorie Green, MD, senior vice president and head of late-stage development at Seagen Inc, stated 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.”
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