FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic... (based primarily on two studies that enro...)

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Date:11/8/2007

based primarily on two studies that enrolled chronic-phase CML patients with resistance or intolerance to Gleevec. A summary of the changes, which are detailed below, include:

-- 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
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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...(based primarily on two studies that enro...)