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Roche CLL drug approved in EU

27 Feb 2009

MabThera, a drug used for the treatment of patients with chronic lymphocytic leukaemia (CLL), has been approved for use in the European Union, its manufacturer has announced.

Roche explains that the therapy has been given the green light for use in combination with chemotherapy in individuals who have not yet been treated for CLL.

The approval for the medication is based on "compelling" data from the CLL8 phase III trial.

Professor Michael Hallek from the University of Cologne, said: "Data from the CLL8 trial suggest that MabThera used in combination with chemotherapy has the potential to become the standard of care for the treatment of CLL."

CLL is the most common type of leukaemia to affect adults and the study found those who used MabThera in tandem with chemotherapy as a first-line therapy for the condition lived for eight more months without their cancer progressing than those who received chemo on its own.

Roche recently commenced a tender offer for outstanding shares of Genentech.