December 17, 2010
Otsuka Pharmaceutical Co., Ltd.
The results of a subset analysis of Japanese patients from the DASISION trial comparing SPRYCEL® (dasatinib) with imatinib in the treatment of newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia.
Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. announced the results of Japanese subset analysis in a Phase III DASISION study on the efficacy of SPRYCEL compared with imatinib for the treatment of patients with newly diagnosed Philadelphia chromosome positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP). In this analysis, the primary endpoint was the confirmed Complete Cytogenetic Response (CCyR*) rate by 12 months. In the Japanese subset analysis, confirmed CCyR was 96% for the SPRYCEL group (26 cases) and 70% for the imatinib control group (23 cases), showing high efficacy of SPRYCEL in the Japanese subset. As for safety profiles, it was concluded that both groups showed good tolerability. The results of this analysis were presented at the 52nd Annual Meeting of the American Society of Hematology, held in Orlando, Florida.
- * Complete cytogenetic response (CCyR) is defined as the state where bone marrow cell genetic evaluation finds no Philadelphia chromosome positive cells undergoing mitosis.
Information in this news release was current as of the original release date.