MabThera Filed In The EU For Treatment Of Most Common Leukaemia In Adults

Main Category: Lymphoma / Leukemia
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Blood / Hematology
Article Date: 01 Aug 2008 - 4:00 PST

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Submission Based on Phase III Study Showing Superior Results for MabThera in Chronic Lymphocytic Leukaemia (CLL) When Added to Standard Chemotherapy

Today, 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.

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% 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% 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.

About the study

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.

Additional information is available on the Internet at http://www.roche.com. All trademarks used or mentioned in this release are legally protected.

Further Information:

- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization