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› FDA Approves U.S. Product Labeling Update For Sprycel (Dasatinib) To Include Three-Year First-Line And Five-Year Second-Line Efficacy And Safety Data In Chronic Myeloid Leukemia In Chronic Phase
FDA Approves U.S. Product Labeling Update For Sprycel (Dasatinib) To Include Three-Year First-Line And Five-Year Second-Line Efficacy And Safety Data In Chronic Myeloid Leukemia In Chronic Phase
2013-06-20 16:10:00| dairynetwork News Articles
Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec®1 (imatinib mesylate)
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