-- A lower recommended starting dose of SPRYCEL 100 mg once daily based on
a dose-optimization trial - the first Phase 3 trial in this patient
population. This once daily dose was associated with a lower frequency
of some side effects (severe myelosuppression and fluid retention).
-- Cytogenetic responses from the first randomized trial of SPRYCEL, 70 mg
twice daily, and Gleevec 800 mg (400 mg twice daily), study -017. For
patients receiving SPRYCEL, at 12 weeks 36 percent achieved a major
cytogenetic response, the study's primary endpoint (29 percent with
Gleevec), and 22 percent achieved a complete cytogenetic response (8
percent with Gleevec). With longer treatment and follow-up, 52 percent
achieved a major cytogenetic response (33 percent with Gleevec), and 40
percent of patients achieved a complete cytogenetic response (16
percent with Gleevec).
The updated SPRYCEL labeling encompasses safety data for a total of 2,182 patients.
"We believe that this filing and its subsequent approval further demonstrates our commitment and dedication to patients with this disease," said Claude Nicaise, M.D., Vice President, SPRYCEL Global Development, Bristol-Myers Squibb. "Bristol-Myers Squibb is fully committed to further exploring and understanding the appropriate use of SPRYCEL through a robust clinical development program."
About the Studies
Dose-Optimization (Study -034): The Phase 3, randomized, open-label
study was conducted in patients with chronic-phase CML, whose disease was
resistant or intolerant to Gleevec, to evaluate the efficacy of SPRYCEL
administered once daily compared with twice daily. The primary endpoint was
major cytogenetic response in patients
|SOURCE Bristol-Myers Squibb Company|
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