The FDA approval of Rituxan plus chemotherapy is indicated for the treatment of children aged six months to 18 years who have various forms of lymphoma or a form of leukemia.
The Food and Drug Administration (FDA) has approved Rituxan (rituximab) in combination with Lymphome Malin B (LMB) chemotherapy for children aged six 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), according to a news release from the agency.
The approval comes following efficacy results of the combination therapy in the Inter-B-NHL Ritux 2010 trial (NCT01516580). Patients received either LMB chemo (which is a combination of corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and an injection of methotrexate/cytarabine/corticosteroid into the spinal canal) alone or in combination with Rituxan at a dose of 375 milligrams (two doses during each of the two indicated courses and one during each of the 2 consolidation courses).
Efficacy was measured as event-free survival (EFS) which included progressive disease, relapse, second malignancy, death from any cause, non-response as evidenced by detection of viable cells in residue after the second course, whichever occurred first.
Results demonstrated that there were 28 and 10 EFS events in the chemotherapy alone group and combination group, respectively. At an interim analysis at a median follow-up of 3.1 years, there were 20 deaths in the chemotherapy alone group compared with eight in the Rituxan combination group.
The most common serious or severe side effects (15% or higher) included febrile neutropenia, inflamed and sore mouth, small intestine inflammation, sepsis (life-threatening infection), increased alanine aminotransferase, and low potassium levels. Side effects that resulted in death occurred in less than 2% of patients across both groups.
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