Posted by Michael Wonder on 11 Feb 2019
European Commission approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
11 February 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia.
This is the second paediatric leukaemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for paediatric patients with acute lymphoblastic leukaemia (ALL) in Europe, the powder for oral suspension formulation of Sprycel.
The approval is based on data from CA180-372, a Phase 2 trial which evaluated the addition of Sprycel to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone in paediatric patients with newly diagnosed Ph+ ALL.
