FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...( - Labeling Now Includes Lower Once-D...)

- Labeling Now Includes Lower Once-Daily Starting Dose and Data from First

Randomized Trial of SPRYCEL and Gleevec(R)*(imatinib mesylate) -

PRINCETON, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today 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. SPRYCEL is indicated for the treatment of adults with chronic-, accelerated-, or myeloid or lymphoid blast-phase 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.

"The new, lower once-daily dose reduces the incidence of some side effects while preserving the efficacy of SPRYCEL for patients with chronic-phase CML no longer responding to currently-approved therapies," said Dr. Hagop Kantarjian, M.D., Chairman and Professor, Leukemia Department, MD Anderson Cancer Center. "Importantly, the new clinical data now included in the labeling provides further evidence to support the use of SPRYCEL to treat patients with chronic-phase CML, if their disease is no longer responding to currently available treatment including Gleevec."

The updated labeling was granted priority review and was approved in six months
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