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FDA Grants Dasatinib Priority Review for Children With Ph+ Chronic Phase CML

Jason Harris
Published: Monday, Jul 10, 2017

Lia Gore, MD

Lia Gore, MD
The FDA has accepted a supplemental new drug application (sNDA) for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia (CP Ph+ CML).

She added that investigators observed only 5 growth and development events, and all were grade 1/2.
Gore L, Kearns P, Lee ML, et al. Phase II trial of dasatinib in pediatric patients with Chronic Myeloid Leukemia in chronic phase. J Clin Oncol 35, 2017 (suppl; abstr 10511).

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