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ZURICH, Oct 29 (Reuters) - U.S. regulators have approved Novartis AG’s NOVN.VX Tasigna drug for use in chronic myeloid leukemia (CML) for patients who no longer respond to Glivec, the Swiss company said on Monday.
Tasigna, which will compete against Bristol-Myers Squibb Co’s (BMY.N) Sprycel, was approved for patients with Philadelphia chromosome-positive (Ph+) CML, Novartis said.
Tasigna could replace use of Glivec, Novartis’s second-biggest seller last year with sales of $2.6 billion, in some situations.
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 is expected to be approved in the European Union by the end of this year. It is already approved in Switzerland and was filed for approval in Japan in June. (Reporting by Sam Cage)