Medical Technology

FDA Approves Rituximab for Multiple Pediatric Cancers

The US Food and Drug Administration yesterday approved rituximab (Rituxan) in combination with chemotherapy for pediatric patients (age 6 months to <18 years) 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). 

Previously, rituximab was approved for use in children 2 years and older for the treatment of granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis. The drug is also approved for use in multiple adult hematologic cancers.

For the new pediatric indications, efficacy was evaluated in Inter-B-NHL Ritux 2010, a global, multicenter, open-label, randomized trial of patients 6 months and older with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.

Advanced stage was defined as stage III with elevated lactose dehydrogenase level (LDH greater than twice the institutional upper limit of normal values) or stage IV B-cell NHL or B-AL.

Patients were randomized to Lymphome Malin de Burkitt (LMB) chemotherapy (corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple drug [methotrexate/cytarabine/corticosteroid] intrathecal therapy) alone or in combination with rituximab.

The main efficacy outcome measure was event-free survival (EFS).

An interim analysis at 53% information fraction was performed in 328 randomly assigned patients with a median follow-up of 3.1 years.

There were 28 EFS events in the LMB-alone group and 10 in the rituximab-LMB group (hazard ratio [HR] 0.32; 90% CI, 0.17 – 0.58; P =.0012). 

At the time of the interim analysis, there were 20 deaths in the LMB-alone arm compared with 8 deaths in the rituximab plus LMB arm.

Randomization was discontinued after the efficacy analysis and an additional 122 patients received rituximab plus LMB chemotherapy and contributed to the safety analysis. 

Adverse reactions (grade 3 or higher, >15%) that occurred with rituximab and chemotherapy were febrile neutropenia, stomatitis, enteritis, sepsis, increased alanine aminotransferase, and hypokalemia. Grade 3 or higher adverse reactions that occurred more often in the rituximab plus LMB chemotherapy arm included sepsis, stomatitis, and enteritis. Fatal adverse reactions occurred in <2% of patients in both study groups. 

The drug carries a Black Box warning about fatal infusion-related reactions within the first 24 hours of rituximab as well as other reactions that may result in death.

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

View full prescribing information for Rituxan here.

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