Regulatory approval

Published by the European Medicines Agency. Approved

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).

This is written in the approval document.

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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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
EMA (1) CD20 + Diffuse Large B-Cell Lymphoma Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine
EMA (1) CD20 + Non-Hodgkin Lymphoma Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine
EMA (1) CD20 + Burkitt Lymphoma Corticosteroid, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Methotrexate, Rituximab, Vincristine

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2020-03-03 European Medicines Agency Indication received approval from the European Commission.