Bristol-Myers Squibb and Otsuka Pharmaceutical have received US Food and Drug Administration approval for Sprycel (dasatinib) as a treatment for newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia in adults.
Approval was based on the open-label Phase II trial that showed that Sprycel demonstrated higher and faster molecular and confirmed complete cytogenetic response rates by 12 months compared to imatinib, the current standard of care.
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Elliott Sigal, executive vice-president of Bristol-Myers Squibb, said that patients now have an option that has improved response over imatinib and offers a once-daily dosing convenience with no fasting requirements.
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