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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.

At a median follow-up of 4.5 years, more than half of the responding patients in the treatment-naïve cohort had not progressed at the time of the data cutoff, and thus, the median duration of CCyR, MCyR, and major molecular response (MMR) could not be estimated. The same was true at the median follow-up time of 5.2 years for the previously treated cohort.

The range of duration of response (DOR) for the newly diagnosed patients was 2.5+ to 66.5+ months for CCyR, 1.4 to 66.5+ months for MCyR, 5.4+ to 72.5+ months for patients who achieved MMR by month 24, and 0.03+ to 72.5+ months for patients who achieved MMR at any time. The ‘+’ denotes a censored observation. Among the imatinib-intolerant cohort, the DOR ranges were 2.4 to 86.9+ months for CCyR, 2.4 to 86.9+ months for MCyR, and 2.6+ to 73.6+ months for MMR.

The 3-, 6-, 12-, and 24-month CCyR rates among newly diagnosed patients were 43.1% (95% CI, 29.3-57.8), 66.7% (95% CI, 52.1-79.2), 96.1% (95% CI, 86.5-99.5), and 96.1% (95% CI, 86.5-99.5), respectively. In the previously treated group, the corresponding rates were 45.7% (95% CI, 30.9-61.0), 71.7% (95% CI, 56.5-84.0), 78.3% (95% CI, 63.6-89.1), and 82.6% (95% CI, 68.6-92.2), respectively.

The 3-, 6-, 12-, and 24-month MCyR rates among treatment-naive patients were 60.8% (95% CI, 46.1-74.2), 90.2% (95% CI, 78.6-96.7), 98.0% (95% CI, 89.6-100), and 98.0% (95% CI, 89.6-100), respectively. The corresponding rates in the imatinib-intolerant group were 60.9% (95% CI, 45.4-74.9), 82.6% (95% CI, 68.6-92.2), 89.1% (95% CI, 76.4-96.4), and 89.1% (95% CI, 76.4-96.4), respectively.

The 3-, 6-, 12-, and 24-month MMR rates among newly diagnosed patients were 7.8% (95% CI, 2.2-18.9), 31.4% (95% CI, 19.1-45.9), 56.9% (95% CI, 42.2-70.7), and 74.5% (95% CI, 60.4-85.7), respectively. The corresponding rates in the previously treated group were 15.2% (95% CI, 6.2-28.9), 26.1% (95% CI, 14.3-41.1), 39.1% (95% CI, 25.1-54.6), and 52.2% (95% CI, 36.9-67.1), respectively.
European Commission Approves Expanded Indication for Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase. Bristol-Myers Squibb. Posted July 5, 2018. Access July 5, 2018. https://bit.ly/2KNWwzW.

 



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