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Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results to Glivec(R) (imatinib) in Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia
Date:12/8/2009

lly well tolerated in the study.(1) A small number of patients discontinued due to adverse events.(1)

"The impressive rates of response observed in this study, combined with the very low rate of disease progression seen in nilotinib-treated patients are very encouraging," said Professor Richard Clark, Consultant Haematologist at Royal Liverpool University Hospital and a trialist involved in this study. "Continued improvement in the treatment of Ph+ CML is very important and these results indicate that nilotinib may provide long-term improvement in progression-free survival."

95% of patients with CML have an abnormality known as the Philadelphia chromosome. This chromosome produces a type of protein called Bcr-Abl, which is responsible for the overproduction of the cancerous white blood cells that are the main feature in Ph+ CML.(3) Nilotinib is a potent and selective inhibitor of the Bcr-Abl protein, thereby inhibiting the production of these cancerous cells.(4,5)

"Novartis has been at the forefront of research on the molecular origin of Ph+ CML and this has led to the development of treatments with unprecedented effectiveness and safety," said Panos Alexakos, Oncology Business Unit Head for Novartis UK. "These data are exciting and the deeper molecular response demonstrated provides hope for further improvement in outcomes for patients with Ph+ CML in the future."

Novartis plans to file worldwide applications for approval of nilotinib as a treatment for adult patients with newly diagnosed Ph+ CML. Nilotinib is currently approved in more than 80 countries including the European Union (EU), United States and other countries for the treatment of adult patients with Ph+ CML in chronic phase or accelerated phase who are resistant or intolerant to prior treatment including imatinib.

Notes to editors

Study details

The clinical trial, Evaluating Nilot
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SOURCE Novartis Oncology
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