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UPDATE 1-Novartis says EU approves Tasigna cancer drug

Wed Nov 28, 2007 1:22am EST

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ZURICH, Nov 28 (Reuters) - The European Commission has approved Novartis AG's (NOVN.VX) Tasigna drug for use in chronic myeloid leukaemia (CML) for patients who no longer respond to Glivec, the Swiss company said on Wednesday.

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Tasigna is a follow up to Glivec, the market-leading drug for the most common type of CML and Novartis's second-biggest seller, with sales of $2.6 billion last year.

The approval in Europe had been expected after Tasigna, which will compete against Bristol-Myers Squibb Co's (BMY.N) Sprycel, was recommended by a European Medicines Agency panel.

The decision applies in all 27 European Union members, plus Norway and Iceland. Tasigna is already approved in the United States and Switzerland, and was filed with regulators in Japan in June.

Novartis has said sales of Glivec, known as Gleevec in the United States, and Tasigna together could be more than $3.5 billion annually.

Tasigna had a rapid path to market, having only been created in August 2002, one year after the launch of Glivec. It works in about half of those patients who develop resistance to Glivec. (Reporting by Sam Cage; editing by Sue Thomas)



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