FDA Approves New SPRYCEL® (Dasatinib) Product Labeling For Patients With Chronic-Phase CML

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for SPRYCEL to include a lower recommended starting dose of 100 mg once daily and safety and efficacy data in a greater number of patients with chronic-phase chronic myeloid leukemia (CML) resistant or intolerant to prior therapy including Gleevec. The product labeling now also includes data from the first randomized trial of SPRYCEL and Gleevec. [click link for full article]

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Filed under: Lymphoma / Leukemia on November 12th, 2007