The FDA approved rituximab combined with chemotherapy for children between 6 months and 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, according to a press release.
The approval follows findings from the Inter-B-NHL Ritux 2010 open-label trial. Patients received either Lymphome Malin B (LMB) chemotherapy alone or with rituximab or non-US licensed rituximab. During the trial, rituximab was given in six infusions of 375 mg/m2, including two doses during the induction courses and one during the consolidation courses. The primary outcome was event-free survival, defined as progressive disease, relapse, secondary malignancy, death from any cause, or non-response.
Results from the trial included a prespecified interim analysis for 328 patients with a median follow-up of 3.1 years. Twenty-eight patients in the LMB group reported an EFS event compared to 10 in the rituximab-LMB group (HR = 0.32; 90% CI, 0.17-0.58; P = 0.0012). In addition, there were 20 deaths in the LMB arm and eight in the combination arm. The estimated overall survival hazard ratio was 0.36 (95% CI, 0.16-0.81). Patients enrolled in the trial were not evaluated for overall survival, with the researchers describing the endpoint as “descriptive.” After the interim analysis, randomization stopped with 122 patients added to the combination treatment group.
The most common adverse reactions grade 3 or higher in pediatric patients included febrile neutropenia, stomatitis, enteritis, and sepsis. Reviewing safety data from the trial, the researchers noted sepsis, stomatitis, and enteritis were more common in the combination arm than chemotherapy alone. Less than 2% of patients in both arms experienced a fatal adverse reaction.
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