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Tasigna, New Drug For CML

Med Headlines - The Food and Drug Administration has approved Tasigna (nilotinib), a new drug for the treatment of Chronic Myeloid Leukemia (CML). Tasigna has been developed by Novartis AG.

Tasigna is to be administered by mouth, twice a day. Since the drug targets Bcr-Abl protein produced by cells with Philadelphia chromosome, it is only indicated for those who are positive for the Philadelphia chromosome. Although the mechanism of action is similar to that of another CML drug, Gleevec, Tasigna has been designed to bind Bcr-Abl protein more preferentially.

In recent studies, Tasigna was associated with reduction or elimination of Philadelphia chromosome in 40% of individuals with chronic stage of CML. “Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy,” said David Epstein, President and CEO of Novartis Oncology. “This approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+ CML patients.”

Tasigna has already been available in Switzerland, and is expected to be approved in the European Union by the end of 2007. It is expected that the sales of Gleevec and Tasigna could top $3.5 billion annually.

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