Posted by Michael Wonder on 05 Jul 2018
European Commission approves expanded indication for Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase
5 July 2018 - Approval includes the first powder for oral suspension formulation of a tyrosine kinase inhibitor developed for administration in paediatric patients.
Bristol-Myers Squibb today announced that the European Commission 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 chronic myeloid leukaemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation. The approval follows a positive opinion issued by the EMA's CHMP on April 26, 2018, and makes Sprycel the first ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in paediatric patients and patients who cannot swallow tablets.
The EC approval is based on data from CA180-226, the largest prospective trial evaluating the safety and efficacy of Sprycel in paediatric patients newly diagnosed with CP-CML, and in those resistant to or intolerant of imatinib.
