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news.Bristol-Myers Squibb said that the FDA has approved new labeling for Sprycel to include a lower recommended starting dose of 100mg once-daily and safety and efficacy data in a greater number of patients with chronic-phase chronic myeloid leukemia resistant or intolerant to prior therapy including Gleevec.
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The product labeling now also includes data from the first randomized trial of Sprycel and Gleevec. Sprycel is indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast-phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including Gleevec.
The effectiveness of Sprycel is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Claude Nicaise, vice president for Sprycel global development at Bristol-Myers Squibb, said: “We believe that this filing and its subsequent approval further demonstrates our commitment and dedication to patients with this disease. Bristol-Myers Squibb is fully committed to further exploring and understanding the appropriate use of Sprycel through a robust clinical development program.”