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FDA Approves Genentech's Rituxan, Chemo for CD20-Positive Pediatric Leukemia, Lymphoma Patients

NEW YORK – The US Food and Drug Administration on Thursday expanded the use of rituximab (Genentech's Rituxan) plus chemotherapy to pediatric patients with certain advanced, treatment-naïve CD20-positive leukemias and lymphomas.

Specifically, the FDA approved the agent for untreated pediatric patients with a variety of advanced CD20-positive non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, Burkitt-like lymphoma, as well as mature B-cell acute leukemia. The agency based its decision on data from the Phase III Inter-B-NHL Ritux 2010 trial, in which patients at least six months old were randomized to receive either rituximab with combination chemotherapy or just combination chemo. To enroll in the trial, patients had to have CD20-positive cancers and had to be younger than 18 years old.

An interim analysis at a median follow-up of around three years showed an event-free survival benefit among patients on the rituximab combination, and the benefit was clear enough that Genentech discontinued randomization. Specifically, there were 28 event-free survival events — defined as disease progression, relapse, second malignancy, death, or non-response — in the chemotherapy arm versus 10 such events in the rituximab-chemo arm. Twenty patients died after receiving just chemo versus eight patients receiving the rituximab combination.

Rituximab is already approved in the US for various adult CD20-positive B-cell non-Hodgkin's lymphoma indications and for adult CD20-positive chronic lymphocytic leukemia.