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.
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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