MabThera approved in the EU for patients with chronic lymphocytic leukaemia

Published: 6-Mar-2009
Media Research & Development

The European Commission has approved Roche's MabThera (rituximab) in combination with chemotherapy for use in patients with previously untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia to affect adults.


The European Commission has approved Roche's MabThera (rituximab) in combination with chemotherapy for use in patients with previously untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia to affect adults.

The approval is based on compelling results from the pivotal phase III study CLL8 conducted by the German CLL Study Group and Professor Michael Hallek at University Hospital Cologne in collaboration with Roche.

At present, CLL is considered incurable and the aim of treatment is to control the disease by managing symptoms and extending the time patients live, without their disease worsening.

The results of CLL8 demonstrated that patients treated with MabThera lived longer without their disease progressing, reducing the number of frequent hospital visits.

"Today's approval of MabThera in CLL is great news for patients suffering from this devastating disease," said William Burns, ceo of Roche Pharmaceuticals division.

"We have seen MabThera transform the lives of more than 1.5m patients with non-Hodgkin's lymphoma (NHL) and we hope this approval will bring about a similar change for people suffering from this condition."

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