PRESSEMITTEILUNGEN

Princeton, New Jersey and Tokyo (ots/PRNewswire) – 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.[1] Results from the 18-month follow up were presented today at the 52nd Annual Meeting of the American Society of Hematology.[1]

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.[1]

“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.[2] 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.

Detailed Study Results From 18-Month Follow-Up

In the DASISION study, 78% of patients treated with SPRYCEL(R) (dasatinib) vs. 70% of patients treated with imatinib achieved confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 18 months (p=0.0366).[1] MMR at any time was 57% for patients treated with SPRYCEL vs. 41% for patients treated with imatinib (p=0.0002).[1] Transformation to accelerated or blast phase occurred in 6 patients receiving SPRYCEL and 9 patients receiving imatinib.[1]

Pleural effusion (all grades) was reported in 12% of those treated with SPRYCEL, and in none treated with imatinib; Grade 3 pleural effusion was reported in

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Bristol Myers Squibb, Bristol Myers Squibb Company, California San Francisco, Chronic Myeloid Leukemia, Chronic Phase, Cml Patients, Congestive Heart Failure, Food And Drug Administration, Food And Drug Administration Fda, Hematology Oncology, Myers Squibb Company, Neil Shah, Otsuka Pharmaceutical Co, Phd Assistant, Philadelphia Chromosome, Pleural Effusion, Princeton New Jersey, Prnewswire, Pyrexia, University Of California San Francisco