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Home Industry News Roche receives FDA approval for leukaemia drug

Roche receives FDA approval for leukaemia drug

22nd February 2010

Roche has earned approval from the Food and Drug Administration (FDA) for a treatment for a common variant of leukaemia.

The pharmaceutical company won ratification for its Rituxan/MabThera drug on the basis of a recent phase III clinical trial, which showed that those using the treatment lived longer than those using chemotherapy alone.

It is hoped that the drug’s approval will prove important in the fight against chronic lymphocytic leukaemia, a form of cancer which accounts for up to 40 per cent of all leukaemia cases in Western nations.

Pascal Soriot, chief operating officer of Roche Pharmaceuticals Division, said Rituxan/MabThera’s benefits come in addition to its previously established efficacy in the treatment of Non-Hodgkin’s lymphoma.

He added that its approval “reinforces the role that this medicine plays in treating blood cancers”.

Earlier this month, Roche reported results from phase III trials of a new diabetes drug, with the findings demonstrating its effectiveness in reducing blood sugar levels.

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