FDA approves rituximab plus chemotherapy for paediatric cancer indications

FDA

3 December 2021 - On 2 December 2021, the FDA approved rituximab (Rituxan, Genentech) 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 leukaemia.

Efficacy was evaluated in Inter-B-NHL Ritux 2010, a global multicenter, open-label, randomised (1:1) trial of patients ≥ 6 months in age with previously untreated, advanced stage, CD20 positive large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukaemia.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics