Posted by Michael Wonder on 10 Nov 2017
U.S. FDA expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
10 November 2017 - Approval based on data from the largest prospective trial in paediatric chronic myeloid leukaemia in chronic phase.
Bristol-Myers Squibb today announced the U.S. FDA has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
This approval for Sprycel in paediatric 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 paediatric studies of 97 patients with CP-CML: an open-label, non-randomised, dose-ranging trial (NCT00306202) and an open-label, non-randomised, single-arm trial (NCT00777036). 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.
