Roche announced the submission of a Marketing Authorisation application to the European Health Authorities for MabThera (rituximab) as a treatment for first line indolent non-Hodgkin's lymphoma in combination with conventional chemotherapy. The application is based on data from a phase III study in which the combination of MabThera plus CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy was significantly superior to CVP chemotherapy alone.

"The benefits of MabThera in this patient group are very compelling and we are very pleased that we are able to submit these important data to the European Health Authorities only a few weeks after the results were presented at the annual meeting of the American Society of Hematology in December," said William Burns, head of Roche Pharmaceuticals Division. "Following the European approval of MabThera in relapsed indolent NHL in 1998, this filing may allow us to double the number of indolent NHL patients who have access to this highly effective drug in the future."

Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45 per cent of NHL patients, is a slow developing but serious cancer of the lymphatic system.

The filing for approval of MabThera in indolent NHL is based on final results from the multi-centre, phase III randomised study, which involved 321 patients from 11 countries and compared a treatment regimen of MabThera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the MabThera plus CVP chemotherapy treatment group.

MabThera is a therapeutic 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 defences 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 is indicated as a single-agent treatment for relapsed or refractory indolent NHL, and received European approval in March 2002 for the treatment of aggressive NHL in combination with CHOP chemotherapy. MabThera is known as Rituxan in the United States, Japan and Canada. More than 300,000 patients have been treated with MabThera worldwide to date. Genentech and Biogen Idec co-market MabThera 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.