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The Food and Drug Administration approved Adcetris plus chemotherapy for pediatric patients with classical high-risk Hodgkin lymphoma.
The Food and Drug Administration (FDA) approved Adcetris (brentuximab vedotin) plus standard-of-care chemotherapy for the treatment of children aged 2 years and older with high-risk classical Hodgkin lymphoma that has not previously been treated.
Hodgkin lymphoma is a blood cancer that starts when a type of white blood cell — lymphocytes — grow out of control, according to a press release from Seagen, the manufacturer of Adcetris. This disease represents approximately 6% of all childhood cancers and is the most commonly diagnosed in adolescents ages 15 to 19 years.
The FDA approval is based off findings from the phase 3 AHOD1331 clinical trial, conducted by the Children’s Oncology Group (COG). The trial included 587 patients between the ages of 2 and 21 with newly diagnosed stage 2B plus bulk, 3B, 4A or 4B high-risk Hodgkin lymphoma. Participants were randomly assigned to receive either standard-of-care chemotherapy (doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide) alone or with Adcetris.
Study data showed that Adcetris plus standard-of-care dose-intense chemotherapy had improved average event-free survival (time from treatment that a patient stays free of complications) compared to the chemotherapy regimen alone.
Further, the Adcetris-containing therapy led to a 59% reduction in the risk of disease progression or relapse, second cancer or death.
“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,” said Dr. Sharon M. Castellino, a professor in the department of Pediatrics at Emory University School of Medicine in Atlanta, in the release. He is also AHOD1331 study chair and COG Hodgkin Lymphoma Disease Committee Chair.
The most common side effects that occurred in at least 20% of patients in the study include fatigue, peripheral neuropathy (weakness, numbness and pain in the hands and feet), diarrhea, nausea, upper respiratory tract infection, neutropenia (too few neutrophils, a type of white blood cell), constipation, fever, hair loss, vomiting, abdominal pain, decreased weight, stomatitis, anemia, mucositis, lymphopenia, febrile neutropenia and low blood platelet count, according to the release.
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