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Pharmaceutical giant Roche has submitted an application for marketing authorisation for the use of its biotechnology drug, MabThera (rituximab) as a first-line treatment of chronic lymphocytic leukaemia (CLL).
The firm has applied to the European Medicines Agency for the authorisation to market the drug which will target the most common form of adult leukaemia.
A phase III clinical trial run by the CLL study group found treatment with MabThera in combination with the current standard chemotherapy achieved a significantly better outcome, compared to patients treated with chemotherapy alone.
The study was powered to show an increase in progression free survival when the MabThera-based combination was used.
CLL mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered a disease that is slow to progress, a significant proportion of patients have the rapidly progressing forms of the disease.
Copyright PA Business 2008
