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Pharmaceuticals / Submissions and Approvals

FDA Expands Sprycel Label to Pediatric Ph+ CML

Nov. 16, 2017

The FDA expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) to include the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. The approval was based on data from 97 pediatric patients with chronic-phase CML from two open-label trials in Phase I and Phase II.

After 24 months of treatment, 96.1 percent of newly diagnosed patients and 82.6 percent of patients resistant or intolerant to Gleevec (imatinib) had complete cytogenic response. With median follow-ups of more than 4.5 years, median durations of response could not be estimated, with more than half of responding patients not progressing at the time of data cut-off, according to the FDA.

The agency granted priority review and an orphan product designation to Sprycel for this indication. Sprycel was first approved in 2006 for adults with Ph+ CML or acute lymphoblastic leukemia resistant to prior therapy. In October 2010, Sprycel received accelerated approval for adults with newly diagnosed Ph+ CML in chronic phase.

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