Roche announced that the European Union's Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of MabThera (rituximab) with any chemotherapy combination as a first-line treatment for chronic lymphocytic leukaemia (CLL), the most common form of adult leukaemia.
The label extension is based on the impressive, highly significant results of the international CLL8 study which showed that the median time until patients progressed with their disease, experienced a relapse or died was 40 months if patients were given MabThera plus chemotherapy compared to just 32 months for those that received chemotherapy alone. MabThera is already licensed for the treatment of non-Hodgkin's lymphoma (NHL). Pending the final approval by the EU authorities, physicians will soon be able to prescribe MabThera to CLL patients in combination with their preferred chemotherapy regimen.
"Treatment with MabThera achieved significantly better outcomes for the patients than chemotherapy alone. This provides hope for the future treatment of a disease that remains life-threatening and incurable," said William M Burns, CEO Roche Pharma. CLL is the most common type of leukaemia in adults, accounting for approximately 25-30 per cent of all forms of leukaemia. Overall incidence of CLL is around three per 100,000 and is twice as common in men compared to women. It mainly affects the elderly with 70-80 per cent of patients diagnosed after the age of 55 and the median age for diagnosis believed to be approximately between 65 and 70 years of age. While CLL is generally considered a disease that is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.
MabThera is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked Bcells.