Rituximab plus chemotherapy is approved by FDA for pediatric cancer indications

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March 2022: The Food and Drug Administration has approved rituximab (Rituxan, Genentech, Inc.) in conjunction with chemotherapy for CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukaemia in children aged 6 months to 18 years (B-AL).

Inter-B-NHL Ritux 2010 (NCT01516580) was a global multicenter, open-label, randomised (1:1) trial of patients aged 6 months and older with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL, with advanced stage defined as Stage III with elevated lactose dehydrogenase (LDH) level (LDH greater than twice the institutional upper limit of normal values) or stage IV B-cell NHL or Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple drug [methotrexate/cytarabine/corticosteroid] intrathecal therapy) was given to patients either alone or in combination with rituximab or non-U.S. According to the LMB scheme, licenced rituximab was administered as six infusions of rituximab IV at a dose of 375 mg/m2 (2 doses during each of the two induction sessions and one dose during each of the two consolidation courses).

EFS was defined as worsening disease, relapse, second malignancy, death from any reason, or non-response as shown by detection of live cells in residual after the second CYVE (Cytarabine [Aracytine, Ara-C], Veposide [VP16]) treatment, whichever came first. In 328 randomised patients with a median follow-up of 3.1 years, an interim effectiveness study at 53 percent information fraction was done. The LMB group had 28 EFS episodes, while the rituximab-LMB group had 10 (HR 0.32; 90 percent CI: 0.17, 0.58; p=0.0012). There were 20 deaths in the LMB chemotherapy arm at the time of the interim analysis, compared to 8 deaths in the rituximab plus LMB chemotherapy arm, for an overall survival HR of 0.36. (95 percent CI: 0.16, 0.81). Overall survival (OS) was not subjected to a rigorous statistical test, and the result is regarded descriptive. After the interim analysis, the randomization was stopped, and an additional 122 patients were given rituximab plus LMB treatment and contributed to the safety analysis.

febrile neutropenia, stomatitis, enteritis, sepsis, elevated alanine aminotransferase, and hypokalemia were the most common adverse events (grade 3 or higher, >15 percent) in paediatric patients treated with rituximab plus chemotherapy. Sepsis, stomatitis, and enteritis were among the grade 3 or higher adverse responses that occurred more frequently in the rituximab plus LMB treatment arm compared to LMB chemotherapy. In both the rituximab plus LMB chemotherapy and LMB chemotherapy arms, fatal adverse events occurred in 2% of patients.

Rituximab is given as an intravenous infusion in combination with systemic LMB treatment at a dose of 375 mg/m2. Six infusions of rituximab are given in total, two doses during each of the induction courses, COPDAM1 [cyclophosphamide, Oncovin (vincristine), prednisolone, Adriamycin (doxorubicin), methotrexate] and COPDAM2, and one dose each of the two consolidation courses, CYM (Cytarabine [Aracytine, Ara-C], methotrexate

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