Roche gains EU approval of subcutaneous MabThera

March 31, 2014 9:20 AM

Roche announced Friday that the European Commission (EC) has approved the 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”, said Sandra Horning, M.D., 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.

The approval of the subcutaneous MabThera formulation follows the clearance in Europe last year of Roche’s subcutaneous formulation of Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer. Roche expects to begin launching MabThera SC in a number of European markets throughout 2014.


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