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U.S. FDA Approves Combination Therapy Across Multiple Pediatric Cancer Indications

December 6, 2021 • 2:22 pm CST
(Vax Before Cancer)

On December 2, 2021, the U.S. Food and Drug Administration Approved rituximab (Rituxan) in combination with chemotherapy for pediatric patients (≥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. 

The recommended rituximab dose is 375 mg/m2 as an intravenous infusion combined with systemic LMB chemotherapy.

In total, six infusions of rituximab are given, two doses during each of the induction courses, COPDAM1 [cyclophosphamide, Oncovin (vincristine), prednisolone, Adriamycin (doxorubicin), methotrexate] and COPDAM2, and one dose during each of the two consolidation courses of CYM (Cytarabine [Aracytine, Ara-C], methotrexate) and CYVE. 

The initial U.S. Approval was issued in 1997. View the complete prescribing information for Rituxan.