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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

FRIMLEY, England, December 8 /PRNewswire/ --

- Nilotinib Surpassed imatinib in Key Measures of Treatment Effectiveness in the Trial, in Patients With Newly-Diagnosed Disease(1)

- At 12-Months, Significantly Fewer Patients Progressed to Later Stages of the Disease on nilotinib (300mg Twice-Daily and 400mg Twice-Daily) Than on imatinib 400mg Once-Daily(1)

- Nilotinib was Generally Well Tolerated; Only a Small Number of Patients Discontinued Due to Adverse Events(1)

- Novartis Plans to File for Use in Newly Diagnosed Patients With Ph+ CML in the EU in 2010

In a large clinical trial, nilotinib demonstrated greater efficacy over the current gold standard treatment, imatinib, in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.(1)

In the first head-to-head study of these two oral treatments as initial therapy for this life-threatening leukaemia, nilotinib demonstrated statistically significant improvement over imatinib in key measures of effectiveness used in the trial.(1) These new data were presented as a late breaker abstract at the 51st annual meeting of the American Society of Haematology (ASH), held 5-8 December 2009, in New Orleans, USA.(1)

CML accounts for more than one in six leukaemias in adults, with around 600 new cases being registered in England and Wales each year.(2) The estimated prevalence of CML in 2003 in England and Wales was 2,660 patients.(2)

The trial showed that at 12 months, significantly fewer patients on nilotinib 300mg twice-daily progressed from the initial chronic phase of the disease to the later accelerated or blast crisis phases than those on imatinib 400mg once-daily.(1) This demonstrates that nilotinib provided significantly better control of the disease compared to imatinib.

Nilotinib was genera
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SOURCE Novartis Oncology
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