Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CD20 + status confers therapeutic sensitivity to Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine in patients with Diffuse Large B-Cell Lymphoma.
The European Medicines Agency (EMA) has authorized rituximab in combination with chemotherapy for the treatment of pediatric patients (aged >= 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL) / Burkitt leukemia (mature B-cell acute leukemia) (BAL) or Burkitt-like lymphoma (BLL). This indication is based on a multicenter, open-label, randomized study of Lymphome Malin B (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.
This statement is based on a regulatory approval from the European Medicines Agency:
MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged >= 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).