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Jul 01, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Sprycel dasatinib regulatory update

The companies said FDA approved an updated label for Sprycel dasatinib to include 3-year data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase chronic myelogenous leukemia (CML) from the Phase III DASISION trial and 5-year data in Ph+ chronic phase CML patients who are resistant or intolerant to Gleevec imatinib in the Phase III Study CA180-034. Three-year data from the open-label, international DASISION trial in 519 patients showed that once-daily 100 mg Sprycel led...

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