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

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 to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2021 The Cancer Letter Inc.