Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co, Ltd announced four-year follow-up results from a phase-3 randomized, open-label, dose-optimization study of Sprycel (dasatinib) in chronic-phase chronic myeloid leukaemia (CML-CP) patients resistant or intolerant to Gleevec (imatinib mesylate). At four years, for all patients administered Sprycel 100 mg once daily, overall survival was 82 per cent (95% CI: 76%-88%) and progression-free survival was 66 per cent (95% CI: 57%-74%).

These data were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

The four-year safety data from this study are consistent with the previously reported safety profile of Sprycel 100 mg once daily. The long-term data from this study also demonstrated that adverse events with Sprycel 100 mg once daily occurred primarily within the first 24 months of treatment.

“These four year-data for Sprycel in the second-line setting add to our growing body of knowledge of this medication and the treatment of CML overall,” said Neil Shah, assistant professor, Division of Hematology/Oncology, University of California, San Francisco and principal investigator of the study. “As a researcher and clinician, I find these results to be very encouraging.”

Sprycel, an oral BCR-ABL inhibitor, is currently approved by the US Food and Drug Administration for the treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec.