September 3, 2009 / 5:34 AM / 10 years ago

UPDATE 1-Roche: Europe approves drug for advanced leukaemia

* EU approves MabThera for relapsed leukaemia

* EU committee already recommended approval in July

* Trial showed MabThera can extend life by 10 months

(Adds details)

ZURICH, Sept 3 (Reuters) - The European Commission has approved Roche Holding AG’s ROG.VX MabThera cancer drug to treat patients whose chronic lymphocytic leukaemia (CLL) returns, the Swiss drugmaker said on Thursday.

The European Union’s Committee on Human Medicinal Products (CHMP) had already issued a positive recommendation in July after a trial showed patients treated with the drug can live 10 months longer without the disease progressing compared with those receiving chemotherapy alone.

MabThera is already approved for first-line use in previously untreated CLL in the EU and in many other countries.

“This approval will make MabThera plus chemotherapy the gold-standard therapy for people living with relapsed or refractory CLL,” said Professor Tadeusz Robak, Medical University of Lodz, Poland, principal investigator for the trial.

CLL is the most common type of leukaemia in adults, accounting for around 30-40 percent of all forms of leukaemia in Western countries. (Reporting by Emma Thomasson; Editing by Mike Nesbit)

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