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Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies
Date:10/29/2007

ients with Ph+ CML.

Tasigna was specifically designed to target the Bcr-Abl protein more preferentially than Gleevec without adding new targets. At six months follow-up, Tasigna reduced or eliminated cells carrying the abnormal Philadelphia chromosome in 40% of patients in chronic phase of the disease.

Applying experience gained from the development of Gleevec, which remains the most frequently prescribed treatment for patients with Ph+ CML, a team of Novartis scientists created Tasigna in August 2002, just a year after the launch of Gleevec. In preclinical studies, the medicine was able to overcome resistance resulting from Bcr-Abl kinase mutations in 32 of 33 cell lines commonly associated with Ph+ CML. Patients with a variety of these mutations also responded to treatment with Tasigna.

The first worldwide approval for Tasigna came in Switzerland in July 2007. European Union approval is expected by the end of this year after the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September. Tasigna was also submitted for approval in Japan in June.

Without treatment, CML typically progresses over three to five years from the initial (chronic) phase through a transition period (accelerated phase) to a rapidly fatal form (blast crisis)(2). Recent landmark clinical trial results for Gleevec show that nearly 90% of newly diagnosed chronic-phase Ph+ CML adult patients treated with Gleevec were alive after five years(3), but some develop resistance or cannot tolerate this therapy.

The FDA approved Tasigna for treatment of chronic-phase and accelerated- phase Ph+ CML in adult patients resistant or intolerant to prior treatment that included Gleevec. This approval is based on an open-label multicenter clinical trial evaluating the drug's safety and rates of cytogenetic response (i.e. reduction or elimination of the Philadelphia chromosome) and hematologic response (i.e. normali
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