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Home Industry News Roche obtains CHMP positive opinion for MabThera

Roche obtains CHMP positive opinion for MabThera

28th July 2009

Roche has announced that it has received positive opinion in Europe for the treatment of patients with its MabThera (rituximab) drug.

In a statement, the company explained that the EU’s Committee on Human Medicinal Products (CHMP) issued the recommendation for the use of the therapy in people with relapsed or refractory chronic lymphocytic leukaemia (CLL).

The recommendation is based on the outcome of the Reach trial, which was the largest randomised clinical trial ever reported in patients with previously-reported CLL.

Commenting, William Burns, chief executive of Roche Pharma, said that the therapy, in combination with chemotherapy, has been proven to give patients significantly more time without their condition returning than chemotherapy alone has.

He added: “The positive opinion will, therefore, be welcomed by doctors and patients alike as it represents hope for the future management of a disease that remains notoriously difficult to treat.”

Earlier this month, the firm announced that Xeloda, in combination with oxaliplatin, is effective in the management of early colon cancer.

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