SPRYCEL® (dasatinib) is indicated for the treatment of adults with
- newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of SPRYCEL (dasatinib) is based on cytogenetic response and major molecular response rates [see Clinical Studies]. The trial is ongoing and further data will be required to determine long-term outcome.
- chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
This approval is based on the study of Lymphoid Blast Phase CML/Ph+ ALL, which enrolled 42 patients with imatinib resistant (92%) or intolerant (8%) lymphoid-blast-phase CML, and 36 patients with imatinib resistant (94%) or intolerant (6%) Ph+ ALL. CML subjects received treatment for a median of 2.8 months (range: 0.1 to 6.4 months), and Ph+ ALL subjects received treatment for a median of 3.2 months (range: 0.2 to 8.1 months). Results yielded efficacy in the trial’s primary endpoint, with Sprycel producing major hematologic respnse in 31% of CML subjects and 42% of Ph+ ALL subjects, including complete hematologic response in 26% and 31% of subjects. In addition, major cytogenetic response in 58% and 58% of subjects.
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Schittenhelm MM, Shiraga S, Schroeder A, Corbin AS, Griffith D, Lee FY, Bokemeyer C, Deininger MW, Druker BJ, Heinrich MC Dasatinib (BMS-354825), a dual SRC/ABL kinase inhibitor, inhibits the kinase activity of wild-type, juxtamembrane, and activation loop mutant KIT isoforms associated with human malignancies. Cancer Research 2006 Jan 1;66(1):473-81