MabThera (rituximab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,prednisolone) chemotherapy. 2
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). 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) CD20 + Diffuse Large B-Cell Lymphoma Cyclophosphamide, Doxorubicin, Prednisolone, Rituximab, Vincristine
Sensitivity (+) CD20 + Non-Hodgkin Lymphoma Cyclophosphamide, Doxorubicin, Prednisolone, Rituximab, Vincristine
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