Bristol-Myers reports Sprycel data

Bristol-Myers Squibb Co. (NYSE:BMY) said Sprycel dasatinib was superior to Gleevec imatinib on the primary endpoint in the Phase III DAISISON trial for the first-line treatment of chronic phase chronic myelogenous leukemia (CML). A significantly greater proportion of patients receiving Sprycel achieved a confirmed complete cytogenetic response (CCyR) at 12 months vs. Gleevec (77% vs. 66%, p=0.007). The open-label trial enrolled 519 patients. Data were published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology meeting in Chicago.

Last week, Bristol-Myers submitted an sNDA to FDA for Sprycel for the indication. An MAA is under review at the European Medicines Agency (EMA). The small molecule inhibitor of BCR-ABL and Src kinases is partnered with Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768). ...