Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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).
Citation
Roche Registration GmbH. MabThera (rituximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf. Revised November 2023. Accessed March 19, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | CD20 + | Diffuse Large B-Cell Lymphoma | Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine | |
| Sensitivity (+) | CD20 + | Non-Hodgkin Lymphoma | Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine | |
| Sensitivity (+) | CD20 + | Burkitt Lymphoma | Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine |