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Dasatinib Approved in Europe for Pediatric Ph+ Chronic Phase CML

Jason M. Broderick @jasoncology
Published: Thursday, Jul 05, 2018

Fouad Namouni, MD

Fouad Namouni, MD
The European Commission (EC) has approved dasatinib (Sprycel) for the treatment of children and adolescent patients aged 1 to 18 years with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), according to Bristol-Myers Squibb (BMS), the manufacturer of the tyrosine kinase inhibitor.

In the United States, the FDA approved dasatinib in November 2017 for the treatment of pediatric patients with Ph+ CP-CML. The FDA approval was based on results with dasatinib demonstrated in 97 pediatric patients with CP-CML enrolled across both the CA180-226 trial and the open-label, nonrandomized, dose-ranging phase I CA180-018 trial (NCT00306202). Fifty-one patients (all from the single-arm trial) were newly diagnosed, and the remaining 46 (29 from the single-arm study and 17 from the dose-ranging trial) were intolerant or resistant to prior imatinib.
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