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Sprycel Gains Full Approval in CML

Bristol-Myers Squibb received full approval from the FDA for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bristol-Myers Squibb received full approval from the FDA for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate). The full approval was based in part on results from a Phase III randomized, open-label dose-optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Glee...

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