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# FDA OKs Rituxan plus Chemo for Pediatric Lymphoma
- URL: https://www.fdaweb.com/fda-oks-rituxan-plus-chemo-for-pediatric-lymphoma/
- Published: 2021-12-06T12:00:00.000Z
- Updated: 2026-09-14T17:24:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150707

FDA has approved Genentech’s Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Approval was based on data from the Inter-B-NHL Ritux 2010 (NCT01516580) randomized trial of patients over six months of age with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL. Patients were randomized to Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple drug \[methotrexate/cytarabine/corticosteroid\] intrathecal therapy) alone or in combination with rituximab or non-U.S. licensed rituximab, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-plus-chemotherapy-pediatric-cancer-indications?ref=fdaweb.com).

FDA says that an interim analysis showed that there were 28 event-free survival events in the LMB group and 10 in the rituximab-LMB group. “At the time of the interim analysis, there were 20 deaths in the LMB chemotherapy arm compared to eight deaths in the rituximab plus LMB chemotherapy arm,” it adds.