FDA Approves Rituximab Plus Chemo for Select Pediatric Hematologic Malignancies

The FDA has approved rituximab plus chemotherapy for previously untreated pediatric CD20-postive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, and mature B-cell acute leukemia following results from the phase 3 Inter-B-NHL Ritux 2010 study.

A combination of rituximab (Rituxan) and chemotherapy was approved by the FDA for the treatment of previously untreated pediatric CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, Burkitt-like lymphoma (BLL), and mature B-cell acute leukemia (B-AL).

The combination was evaluated as part of the phase 3 Inter-B-NHL Ritux 2010 study (NCT01516580), which focused on patients who were 6 months or older with previously untreated advanced CD20-positive DLBCL, Burkitt lymphoma, BLL, and B-AL. Findings from a prespecified interim analysis indicated that, after a median follow-up of 3.1 years, a total of 28 event-free survival (EFS) events took place within the Lymphome Malin B (LMB) cohort compared with 10 in the rituximab/LMB cohort (HR, 0.32; 90% CI, 0.17-0.58; P = .0012).

Twenty deaths were reported in the chemotherapy alone group vs 8 deaths in the rituximab arm, with an estimated overall survival (OS) HR of 0.36 (95% CI, 0.16-0.81). However, no formal statistical test for OS was conducted and the findings are considered to be descriptive.

Common adverse effects (AEs) among patients who received the rituximab regimen included febrile neutropenia, stomatitis, enteritis, sepsis, increased alanine aminotransferase, and hypokalemia. Additionally, grade 3 or higher AEs included sepsis, stomatitis, and enteritis.


FDA approves rituximab plus chemotherapy for pediatric cancer indications. News release. FDA. December 3, 2021. Accessed December 3, 2021. https://bit.ly/3GcfUQl