Basel, July 25, 2007
Switzerland has granted the first worldwide approval for Tasigna (nilotinib), a potent and novel targeted cancer therapy for patients with a form of the life-threatening blood cancer chronic myeloid leukemia (CML) who are resistant or intolerant to treatment with Glivecâ (imatinib)[1] - the leading therapy for CML patients also developed by Novartis.
The approval of Tasigna came after an accelerated review by the Swiss health authority Swissmedic based on positive findings from a pivotal Phase II trial. Trial results showed high response rates in these patients with a generally well-tolerated, manageable safety profile.
Taken twice-daily, Tasigna inhibits production of cancer cells containing an abnormal chromosome by targeting the Bcr-Abl protein. This protein, which is produced by cells containing the abnormal Philadelphia chromosome, is recognized as the key driver of the overproduction of cancer-causing white blood cells in patients with CML.
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