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Sprycel approved for first-line CML

October 29, 2010 12:55 AM UTC

FDA granted accelerated approval for an sNDA from Bristol-Myers Squibb Co. (NYSE:BMY) for Sprycel dasatinib to treat newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase. As part of the approval, Bristol-Myers is required to collect additional long-term efficacy and safety data. ...