Bristol-Myers (BMY), Otsuka Receive FDA Approval for Sprycel Label Update
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka America Pharmaceutical, Inc. 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 GleevecÂ®1 (imatinib mesylate).
Sprycel is a kinase inhibitor indicated for the treatment of adults with newly diagnosed CP Ph+ CML. The effectiveness of Sprycel is based on cytogenetic response and major molecular response rates. The trial is ongoing and further data will be required to determine long-term outcome. Sprycel is also indicated for Ph+ CML in all phases (chronic, accelerated, or myeloid or lymphoid blast) with resistance or intolerance to prior therapy including imatinib and Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.
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