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MabThera increases the time patients with the most common form of adult leukaemia live without their cancer progressing


Pivotal Phase III study with MabThera reaches primary endpoint in first line treatment for patients with Chronic Lymphocytic Leukaemia

Roche announced today that their innovative biotech drug MabThera (rituximab) can significantly increase the time before the disease progresses in patients suffering from the most common form of adult leukaemia, Chronic Lymphocytic Leukaemia (CLL).

The pivotal CLL8 trial, initiated by the German CLL study group, successfully met its primary endpoint, by showing that patients treated with MabThera in combination with the current standard chemotherapy achieved a significant improvement in progression free survival, compared to patients treated with chemotherapy alone.

“The outcome of this trial represents an important advance in the treatment of this life-threatening disease, where there is currently a high unmet medical need, ” said William M. Burns, CEO Pharmaceuticals Division of Roche. “That the study reached its primary endpoint almost a year ahead of schedule indicates the important role MabThera will have in the treatment of CLL.”

Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in adults, accounting for approximately 25-30% of all forms of leukaemia. Incidence of CLL in Western countries is around 2-4 per 100,000, and is twice as common in men as in women. It mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered an indolent disease, meaning that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.

This study will form the basis of the regulatory filing in the EU later in the year to extend the use of MabThera for the treatment of first-line CLL. Data from this trial will be submitted for presentation at upcoming international scientific meetings.
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