FDA Approves Brentuximab Vedotin for Pediatric Patients With Previously Untreated, High-risk Hodgkin Lymphoma

FDA

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

The decision is supported by findings from the phase 3 AHOD1331 trial, in which the addition of the antibody-drug conjugate (ADC) to AVE-PC significantly improved event-free survival over standard-of-care treatment with ABVE-PC (doxorubicin, belomycin, vincristine, etoposide, prednisone, and cyclophosphamide) in this patient population. Those in the investigative arm experienced a reduction in the risk of disease progression or relapse, second cancer, or death of 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.”

AHOD1331, which was conducted by the Children's Oncology Group and sponsored by the National Cancer Institute, is the largest multicenter, randomized, open-label, phase 3 trial to be performed in pediatric patients with newly diagnosed, high-risk Hodgkin lymphoma.

The trial enrolled a total of 587 patients who ranged in age from 2 years to 21 years. To participate, 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 randomly assigned 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 served as the primary objective of the research.

Reference

Seagen announces US FDA approval of new indication for Adcetris (brentuximab vedotin) for children with previously untreated high risk Hodgkin lymphoma. News release. Seagen Inc. November 10, 2022. Accessed November 15, 2022. http://bit.ly/3AfJWCo