FDA approves Rituxan plus chemotherapy for pediatric lymphoma, leukemia
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The FDA approved rituximab in combination with chemotherapy for several pediatric cancer indications.
The approval applies to use of the regimen for patients aged 6 months to 18 years with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma or mature B-cell acute leukemia.
Rituximab (Rituxan; Genentech, Biogen), a chimeric monoclonal antibody that targets CD20, is approved in the United States for multiple cancer indications.
The FDA based the new indications on results of the randomized Inter-B-NHL Ritux 2010 trial, which included patients aged 6 months or older with previously untreated, advanced-stage, CD20-positive DLBCL, Burkitt lymphoma, Burkitt-like lymphoma or mature B-cell acute leukemia.
Researchers randomly assigned half of the patients to Lymphome Malin de Burkitt chemotherapy, which consists of corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide and triple-drug (methotrexate/cytarabine/corticosteroid) intrathecal therapy. The other half of patients received chemotherapy plus rituximab administered as six IV infusions of 375 mg/m2. Patients received two rituximab doses during each of two induction courses, and one dose during each of two consolidation courses.
EFS served as the main efficacy outcome.
A prespecified interim efficacy analysis performed after median follow-up of 3.1 years showed 28 EFS events among patients assigned chemotherapy alone and 10 among those assigned chemotherapy plus rituximab (HR = 0.32; 90% CI, 0.17-0.58).
Twenty deaths occurred in the chemotherapy group and eight occurred in the chemotherapy-rituximab group (estimated HR for OS = 0.36; 95% CI, 0.16-0.81).
Grade 3 or higher adverse events that occurred among more than 15% of patients assigned chemotherapy plus rituximab included febrile neutropenia, stomatitis, enteritis, sepsis, increased alanine aminotransferase and hypokalemia.
Fatal adverse reactions occurred in fewer than 2% of patients in both treatment groups.
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