FDA approves dasatinib for pediatric Ph+ CML

The Food and Drug Administration has approved dasatinib for children with Philadelphia chromosome–positive (Ph+) chronic phase chronic myeloid leukemia (CML).

The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.

Median follow-up was 4.5 years for newly diagnosed patients and 5.2 years for patients who were resistant to or intolerant of imatinib, the FDA reported. Because more than half of the responding patients had not progressed at the time of data cutoff, the investigators could not estimate median durations of complete cytogenetic response, major cytogenetic response, and major molecular response.

Adverse reactions to dasatinib included headache, nausea, diarrhea, skin rash, vomiting, pain in extremities, abdominal pain, fatigue, and arthralgia; these side effects were reported in approximately 10% of patients.

Dasatinib is marketed as Sprycel by Bristol-Myers Squibb.

The recommended dose of dasatinib for pediatric patients is based on their body weight. Full prescribing information is available here.

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