The European Commission (EC) expanded the indication for Sprycel to include the treatment of children and adolescents with Philadelphia chromosome-positive CML.- BMS

Bristol-Myers Squibb Company announced that the European Commission (EC) has expanded the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation. The approval follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use on 26 April 2018, and makes Sprycel the first ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in pediatric patients and patients who cannot swallow tablets.

The EC approval is based on data from CA180-226 (NCT00777036), the largest prospective trial evaluating the safety and efficacy of Sprycel in pediatric patients newly diagnosed with CP-CML, and in those resistant to or intolerant of imatinib.