MabThera indications extended

The monoclonal antibody MabThera (rituximab) has received regulatory approval for two additional indications, rheumatoid arthritis and non-Hodgkin's lymphoma.

In rheumatoid arthritis, MabThera may be used in combination with methotrexate for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying antirheumatic drugs including one or more tumour necrosis factor inhibitor therapies.
The efficacy of MabThera in alleviating the signs and symptoms of rheumatoid arthritis has been shown in three multicentre trials in which rituximab 2 x 1000mg significantly increased the proportion of patients achieving at least a 20% improvement in ACR (American College of Rheumatology) score compared with patients treated with methotrexate alone.

In non-Hodgkin's lymphoma, MabThera may be used as maintenance therapy in patients with relapsed/refractory follicular disease responding to induction therapy with chemotherapy with or without MabThera.

This licence extension was granted following the results of a trial in which patients who responded to induction treatment and who received MabThera maintenance treatment consisting of a single infusion of MabThera at 375mg/m2 every three months had significantly improved outcome in terms of disease progression, relapse and death compared with those in the control group.

Further information: Roche Products Ltd, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Herts AL7 1TW. Tel: (01707) 366000.

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