European Commission approves Sprycel for pediatric patients with (Ph+) acute lymphoblastic leukemia. -BMS

Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This is the second pediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension (PFOS) formulation of Sprycel.

The approval is based on data from CA180-372 (NCT01460160), a Phase II trial which evaluated the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL. Results from the CA180-372 trial presented at the 2017 American Society of Hematology Annual Meeting showed that at three years, the combination of Sprycel and chemotherapy demonstrated an event-free survival (EFS) rate, the study�s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5).