Bristol-Myers: U.S. FDA expands approval of Sprycel
Bristol-Myers announced the U.S. FDA has expanded the indication for Sprycel tablets to include the treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA. The safety and efficacy of Sprycel in pediatric patients was evaluated in two pediatric studies of 97 patients with CP-CML: an open-label, non-randomized, dose-ranging trial and an open-label, non-randomized, single-arm trial. Among the 97 patients in the two studies, 51 patients (exclusively from the single-arm trial) had newly diagnosed CP-CML, and 46 patients (17 from the dose-ranging trial and 29 from the single-arm trial) were resistant or intolerant to previous treatment with imatinib.