EMA Approves Roche's MabThera SC For Non-Hodgkin Lymphoma
Roche recently announced it has secured approval from the European Commission for the new subcutaneous formulation of MabThera (rituximab) for the treatment of common forms of non-Hodgkin lymphoma in patients. The approval follows the recent authorization of Herceptin SC in September 2013.
The EC approved MabThera for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. The approval was based on data from the pivotal SABRINA study, which was published in The Lancet Oncology.
Sandra Horning, CMO and Head, Global Product Development, said, “As part of our mission to improve people’s lives, we are pleased that MabThera SC has been approved for patients with common forms of non-Hodgkin lymphoma. We believe that the faster five minute administration will significantly improve the treatment experience for patients and providers compared to the approximate 2.5 hour infusion time for intravenous MabThera.”
Non-Hodgkin lymphoma represents an estimated 85% of all diagnosed lymphoma cases and accounted for around 200,000 deaths per year worldwide in 2012. Lymphomas affect the lymphatic system, which helps protect the body against disease. The cancer develops when white blood cells, usually B-lymphocytes, in the lymph fluid become cancerous. The cells begin to increase uncontrollably and collect in the lymphatic tissues or lymph nodes, spreading through the body and interfering with the production of healthy blood cells.
MabThera is a therapeutic monoclonal antibody designed to bind to the CD20 antigen on the surface of normal and malignant B-cells. The drug triggers the body’s natural defenses to target and destroy the marked cancerous B-cells. Stem cells (B-cell progenitors) found in the bone marrow lack the CD20 antigen which allows healthy B-cells to regenerate after treatment and return to normal levels within several months of therapy.
The drug is marketed as Rituxan in the U.S., Japan, and Canada. Roche said it plans to launch MabThera SC in several European markets throughout 2014.