Annotation of EMA Label for rituximab and MS4A1

Summary

The EMA European Public Assessment Report (EPAR) for rituximab (MabThera) contains information regarding one of the indications of the drug in patients with CD20-positive diffuse large B cell non-Hodgkin's lymphoma. The drug targets CD20 (MS4A1)-expressing B cells to induce cell lysis.

Annotation

Rituxumab is an antibody that specifically binds the CD20 antigen expressed on B cells to induce B cell lysis. It is indicated for treatment of subsets of patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Excerpts from the rituximab (MabThera) EPAR:

Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95% of all B-cell non-Hodgkin’s lymphomas. CD20 is found on both normal and malignant B-cells, but not on haematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissue. This antigen does not internalise upon antibody binding and is not shed from the cell surface. CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.

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.

MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged 6 months to less than 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).

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the rituximab EPAR.

*Disclaimer: The contents of this page have not been endorsed by the EMA and are the sole responsibility of PharmGKB.

Evidence for Clinical Annotations

This annotation has been used as evidence for the following clinical annotations.

    History

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