FDA News

FDA Clears for New Sprycel Product Labeling for Patients with Chronic-Phase CML

(Nov 11, 2007)-- Bristol-Myers Squibb Company 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 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."

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