Study SPRYCEL

Bristol-Myers Squibb Company (http://www.bms.com) and Otsuka Pharmaceutical Co., Ltd. today announced 18-month follow-up results from the Phase 3 DASISION study of SPRYCEL(R) (dasatinib) 100 mg once daily vs. imatinib (400 mg daily) in the first-line treatment of adults with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML). Results at 18 months were consistent with 12 month data in which SPRYCEL demonstrated higher and faster rates of complete cytogenetic response (CCyR) and major molecular response* (MMR) compared to imatinib.
Results from the 18-month follow up were presented today at the 52nd Annual Meeting of the American Society of Hematology.
Safety data from DASISION demonstrated that the most frequently reported serious adverse reactions with SPRYCEL included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%) and pyrexia ( 1%). Commonly reported adverse events (greater than or equal to 10%, of all grades) with SPRYCEL and imatinib included superficial edema (10% and 36%), pleural effusion (12% and 0%), myalgia (22% and 38%), nausea (9% and 21%), vomiting (5% and 10%), diarrhea (18% and 19%), fatigue (8% and 11%), headache (12% and 10%) and rash (11% and 17%).[1] Overall rates of fluid retention observed in the study were 23% with SPRYCEL and 43% with imatinib.
"The follow up results from DASISION are important as they continue to support the use of SPRYCEL as a first-line treatment option for newly-diagnosed Ph+ CP-CML patients," said Neil Shah, MD, PhD, Assistant Professor, Division of Hematology/Oncology, University of California, San Francisco, and presenter of the study results.
On October 28, 2010, the U.S. Food and Drug Administration (FDA) approved SPRYCEL 100 mg once daily for newly diagnosed adults with Ph+ CP-CML based on the twelve-month results from DASISION, which were published in the New England Journal of Medicine[2] and presented at the 46th Annual Meeting of the American Society of Clinical Oncology earlier this year. The effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. The DASISION trial is ongoing and further data is required to determine long-term outcome.