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Tuesday 11 July 2006

Roche's MabThera gets new EU lymphoma OK

By: Helen Marshall

The European Commission has approved Roche's MabThera as maintenance therapy for patients with relapsed or refractory follicular non-Hodgkin's lymphoma, a common form of lymphoma.

MabThera (rituximab) is already approved in the EU for first-line treatment of both aggressive and indolent non-Hodgkin's lymphoma (NHL), in combination with chemotherapy, and as a second-line monotherapy for indolent NHL.

The label extension is based on the impressive results of the EORTC 20981 study, which was performed in 18 countries worldwide, and gives patients with relapsed follicular NHL a better chance to live disease-free for longer, allowing them up to an additional three years without new chemotherapy treatments.

In addition, MabThera maintenance therapy has been shown to reduce the risk of death by almost half (48%) for patients with this form of NHL, compared to standard disease management.

"Maintenance therapy with MabThera is the first treatment in 30 years that prolongs the life of these patients to such an extent," said William Burns, CEO of Roche's pharmaceuticals division. "The quick approval of MabThera maintenance therapy mirrors the dramatic survival benefit this medicine can bring to the patient providing new hope to control the disease."

In related news, Roche also announced that MabThera has been approved by the European Commission for the treatment of rheumatoid arthritis in Europe.

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