FDA Grants Dasatinib Priority Review for Resistant CML

PRINCETON, New Jersey—The FDA has granted priority review to dasatinib (BMS-354825), developed by Bristol-Myers Squibb, for treatment of imatinib (Gleevec)-resistant or refractory chronic myelogenous leukemia (CML) in adults. Dasatinib, an oral, small-molecule tyrosine kinase inhibitor, exhibits greater potency than imatinib and inhibits the majority of kinase mutations resistant to imatinib. The new drug application also seeks approval of dasatinib for treatment of Philadelphia chromosome-positive adult acute lymphoblastic leukemia.