medwireNews: Children with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase may now be treated with the tyrosine kinase inhibitor (TKI) dasatinib, the US Food and Drug Administration has announced.
The approval follows phase I and phase II trial findings of dasatinib in both patients with newly diagnosed chronic phase CML and in children who have developed resistant or intolerance to the TKI imatinib, most of whom were treated at a dose of 60 mg/m2 once daily. After 2 years of treatment, a complete cytogenetic response was achieved by 96.1% and 82.6% of the newly diagnosed and imatinib-resistant patients, respectively.
Dasatinib may be dosed according to body weight and adverse reactions reported in at least 10% of pediatric patients include headache, nausea, and diarrhea.
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