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FDA OKs Novartis Cancer Drug

Tasigna, a chronic myeloid leukemia treatment, will be available in the U.S. within days.


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said Monday afternoon that the Food and Drug Administration approved its second-line treatment for chronic myeloid leukemia (CML), a life-threatening blood cancer that's one of the four most common types of leukemia.

The FDA approved Tasigna for adults with Philadelphia chromosome-positive (Ph+) CML who are resistant or intolerant to prior treatment, including Novartis' Glivec.

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Novartis said it will make the twice-daily drug available in the U.S. within days. It was approved in Switzerland in July 2007, and Novartis expects an approval in the European Union by the end of this year. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September recommending the drug be approved. Tasigna was also submitted for approval in Japan in June.

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