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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.

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Approval for younger patients was based on data from 97 pediatric patients with chronic phase CML evaluated in two nonrandomized trials. Twenty-four months of treatment with dasatinib resulted in complete cytogenetic response for 96.1% of 51 newly diagnosed patients (95% confidence interval, 86.5%-99.5%) and for 82.6% of 46 patients resistant to or intolerant of imatinib (95% CI, 68.6%-92.2%), the FDA said in a press statement.

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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