Roche submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for the use of its biotechnology drug MabThera (rituximab) as first-line treatment of chronic lymphocytic leukaemia, the most common form of adult leukaemia.
The filing is based on data from the Pivotal phase III CLL8 study (ML17102), initiated by the German CLL Study Group (GCLLSG), which showed at interim analysis that 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.
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 B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
Full results of the CLL8 study will be submitted for presentation at the annual meeting of the American Society of Haematology (ASH) in San Francisco in December this year.
Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in adults, accounting for approximately 25-30 per cent 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 compared to women. It mainly affects the elderly with 95 per cent of patients diagnosed after the age of 55. While CLL is generally considered a disease that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.
The CLL8 study is an international study and included 817 patients with CLL receiving first-line treatment. The study was conducted at 191 study sites across 11 countries. In this randomized study, patients received either MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The primary endpoint of the study was progression free survival. No new or unexpected safety signals were observed.
MabThera is indicated for the treatment of patients with stage III and IV follicular Non-Hodgkin's Lymphoma and patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma. MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera is known as Rituxan in the United States, Japan and Canada. To date, patients have received more than 1 million treatments with MabThera worldwide.
Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.