Roche has received the European Commission (EC) approval for a new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche’s oncology products.

“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 (NHL)”, said Sandra Horning, chief medical officer and head, global product development. “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 European approval was based primarily on data from the pivotal SABRINA study, which was recently published in The Lancet Oncology.

Roche expects to begin launching MabThera SC in a number of European markets throughout 2014.

MabThera is a therapeutic monoclonal antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera (Rituxan in the United States, Japan and Canada), discovered by Biogen Idec, 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). MabThera 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. For more than 15 years, the efficacy and safety of MabThera has been documented in more than 300 phase II/III clinical studies. MabThera has been approved for the treatment of several blood cancers, specifically, certain types of NHL and for chronic lymphocytic leukaemia (CLL). It continues to be studied in other types of blood cancers and disease areas where CD20-positive cells are believed to play a role.

MabThera is known as Rituxan in the United States, Japan and Canada. Genentech, a member of the Roche Group, and Biogen Idec collaborate on Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.