Rituximab Plus Chemotherapy Approved by FDA for Select Pediatric Cancers
Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.
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
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