The European Commission (EC) has approved Roche’s new subcutaneous (SC) formulation of MabThera (rituximab) for treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.
This is the second European approval for a new subcutaneous formulation of one of Roche’s oncology products and follows the approval of Herceptin SC in September 2013.
MabThera is a therapeutic monoclonal antibody that binds to a particular protein, the CD20 antigen, on the surface of normal and malignant B-cells and later it recruits the body’s natural defences to attack and kill the marked B-cells.
Stem cells in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
Roche chief medical officer and head of global product development Sandra Horning said: "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."
The approval is based on data from a major SABRINA study, which was recently published in The Lancet Oncology.
The company intends to start launching MabThera SC in a number of European markets throughout 2014.
Discovered by Biogen Idec, mabThera is marketed under the trade name Rituxan in the US, Japan and Canada.
Genentech, a member of the Roche Group, and Biogen Idec collaborate on Rituxan in the US, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo.
MabThera first received FDA approval for the treatment of relapsed indolent non-Hodgkin Lymphoma (NHL) in 1997 and was the first targeted cancer medicine approved by the US Food and Drug Administration (FDA).
The drug was approved in the EU in June 1998, and has since been used to treat more than 2.7 million people with specific blood cancers.
Image: Micrograph of a diffuse large B cell lymphoma. Field stain. Photo: courtesy of Nephron.