publication date: Feb. 15, 2019
Drugs & Targets European Commission approves Sprycel + chemo for pediatric
The European Commission has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
Sprycell is sponsored by Bristol-Myers Squibb Co.
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 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 rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival rate of 91.5% (95% CI: 84.2 to 95.5).
The safety profile of Sprycel administered in combination with chemotherapy in pediatric patients with Ph+ ALL in the CA180-372 trial was consistent with the known safety profile of Sprycel in adults with Ph+ ALL and the known safety … Continue reading European Commission approves Sprycel + chemo for pediatric
To access this members-only content, please log in.
Institutional subscribers, please log in with your IP
If you're not a subscriber why not join today?
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.