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Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia
Date:12/8/2008

y Grade 2 and 3 non-hematologic adverse events decreased considerably between months one to three and months four to six(2).

The second study, conducted by researchers at MD Anderson Cancer Center, is an ongoing Phase II clinical trial investigating the efficacy and safety of Tasigna as initial therapy for patients with CML-CP (chronic phase). The current analysis, which includes data from 48 patients, shows that nearly all evaluable patients (96%) achieved CCyR. By six and 12 months, 45% and 52% of patients achieved MMR, respectively. Adverse reactions were manageable with temporary treatment interruptions or dose reductions(1). Notably, there was no marked incidence of severe fluid retention or effusions, side effects commonly observed with other drugs of this class.

About Tasigna

Tasigna (nilotinib) capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. Tasigna has been approved in more than 50 countries. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Please see Important Safety Information, including Warning below.

Tasigna important safety information

    WARNING: QT PROLONGATION AND SUDDEN DEATHS

    TASIGNA prolongs the QT interval. Sudden deaths have been reported in
    patients receiving nilotinib. TASIGNA should not be used in patients with
    hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or
    hypomagnesemia must be corrected prior to TASIGNA administration and
    should be periodically monitored. Drugs known to prolong the QT interval
    and strong CYP3
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SOURCE Novartis
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