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 roche. All trademarks used or mentioned in this release are
legally protected.
Further Information:
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization