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 profile of the chemotherapy regimen.
Primary toxicities of any causality included hematological toxicity such as grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%) and bacteremia (24.5%). Non-hematologic, non-infectious grade 3 or 4 adverse events (AEs) attributed to Sprycel and reported in more than 10% of patients were limited to elevated alanine aminotransferase (21.7%) and aspartate transaminase (10.4%). Other grade 3 … Continue reading European Commission approves Sprycel + chemo for pediatric
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