Dasatinib Granted Regular FDA Approval for Ph+ CML in Pediatric Patients

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Approval to dasatinib for the treatment of pediatric patients with Ph+ CML was granted based of data from two clinical trials.
Approval to dasatinib for the treatment of pediatric patients with Ph+ CML was granted based of data from two clinical trials.

Based on data from 97 pediatric patients with chronic phase chronic myeloid leukemia (CML), the US FDA granted regular approval to dasatinib (Sprycel) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) CML in the chronic phase. Prior FDA approval for this indication was granted as priority review and orphan drug designation.1

The patients evaluated were from 2 trials: a phase 1, open-label, nonrandomized, dose-ranging trial and a phase 2, open-label, nonrandomized trial. Of the 97 patients, 51 patients were exclusively from the phase 2 trial and had newly diagnosed chronic phase CML; and 46 were resistant or intolerant to previous treatment with imatinib. This second group included 17 patients from the phase 1 trial and 29 from the phase 2 trial.

Most patients were treated with dasatinib 60 mg/m2 once daily until disease progression or unacceptable toxicity.

After 24 months of treatment, complete cytogenic response (CCyR) was achieved in 96.1% of patients with newly diagnosed disease (95% CI, 86.5, 99.5) and 82.6% of patients whose disease was resistant or intolerant to imatinib (95% CI, 68.6, 92.2). However, at a median follow-up of 4.5 years in the new diagnosis group and 5.2 years in the imatinib resistant/intolerant group, disease progression had not occurred in more than half of the responding patients at data cut-off, therefore median durations of CCyR, major cytogenic response (MCyR), and major molecular response (MMR) could not be estimated.

The most common adverse reactions, reported in 10% of more of patients treated with dasatinib, were headache, nausea, diarrhea, skin rash, vomiting, pain in extremity, abdominal pain, fatigue, and arthralgia.

Dose recommendations for pediatric patients is based on body weight, administered daily with or without food: 10 to <20 kg, 40 mg; 20 to <30 kg, 60 mg; 30 to <45 kg, 70 mg; 45 kg or more, 100 mg. Dose should be recalculated every 3 months based on changes in body weight, or more often if necessary.2

Full prescribing information is available at www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf.


1. FDA approves dasatinib for pediatric patients with CML [news release]. Silver Spring, MD: U.S. Food and Drug Administration; November 9, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584725.htm?utm_campaign=Oncology%2011%2F13&utm_medium=email&utm_source=Eloqua&elqTrackId=e3fc8b51cc174a8eaf2296d2df9e04e1&elq=cb084bca21944456ae0fd49ef8c8cb3c&elqaid=1301&elqat=1&elqCampaignId=784. Last Updated November 13, 2017. Accessed November 13, 2017.

2. Sprycel® [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf. Accessed November 13, 2017.

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