Rituximab Plus Chemotherapy Approved by FDA for Select Pediatric Cancers

FDA approved Genentech’s rituximab (Rituxan) in combination with chemotherapy for pediatric patients (6 months of age and older to 18 years of age) 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), according to a Dec. 2, 2021, press release.

When given as an intravenous infusion given in combination with systemic Lymphome Malin B (LMB) chemotherapy, the recommended rituximab dose is 375 mg/m². Six total infusions of rituximab are given.

A global multicenter, open-label, randomized trial was performed, assessing patients six months in age or older with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL. Event-free survival was the main efficacy outcome measure. This was defined as a progressive disease, relapse, second malignancy, death from any cause, or non-response as evidenced by detection of viable cells in residue after the second Cytarabine Aracytine, Ara-C, Veposide course. There were 20 deaths in the LMB chemotherapy arm compared to 8 deaths in the rituximab plus LMB chemotherapy arm at the time of the interim analysis.

Source: FDA