Sprycel gains indication for Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML)
Bristol-Myers Squibb announced that the FDA granted accelerated approval to Sprycel (dasatinib) for the first-line treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML). This approval was based on data from an open-label, randomized clinical trial in patients with CP-CML that evaluated the efficacy of Sprycel. The study measured complete cytogenetic response (CCyR) and cytogenetic response (MCyR).Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells. Sprycel is already indicated for the treatment of chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. Sprycel is also approved for treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
For more information call (800) 321-1335 or visit www.sprycel.com/hcp/index.aspx.