EC OKs New Formulation of Roche’s MabThera
The European Commission (EC) has approved the subcutaneous (SC) formulation of Roche’s MabThera (rituximab) for people with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). The approved dose for CLL is 1600 mg. Following the approval of MabThera SC (1400 mg) for common forms of non-Hodgkin lymphoma in March 2014, this is the second European approval for the formulation.
MabThera is known as Rituxan in the United States, Japan and Canada. Genentech, a member of the Roche Group, and Biogen 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.
MabThera first received approval from the US Food and Drug Administration for the treatment of relapsed indolent non-Hodgkin Lymphoma (NHL) in 1997. MabThera was approved in the EU in June 1998. MabThera has been approved for the treatment of several blood cancers, specifically, certain types of NHL and for chronic lymphocytic leukemia.