Chronic myeloid leukemia (CML) is a rare hematopoietic stem cell disease that is typically characterized by the abnormal BCR-ABL1 fusion gene on the Philadelphia (Ph) chromosome in neoplastic cells. Dasatinib (Sprycel®) is an orally administered, small molecule tyrosine kinase inhibitor indicated for the treatment of certain hematological malignancies, including Ph-positive CML in the chronic phase (Ph+ CML-CP) in adult and pediatric patients. In open-label phase 1 and phase 2 clinical trials, dasatinib produced early and durable target responses (i.e. molecular, cytogenetic and/or hematologic) in pediatric patients with Ph+ CML-CP that was newly diagnosed or resistant/intolerant to imatinib, with some recipients of the drug also experiencing deep molecular responses. Dasatinib therapy in pediatric patients with Ph+ CML-CP was reported to have a similar safety profile to that observed in adults, except there were no occurrences of pleural effusion, pericardial effusion, pulmonary edema, or pulmonary hypertension adverse events. Although long-term outcomes remain to be determined, dasatinib expands the first- and second-line options available for the treatment of Ph+ CML-CP in pediatric patients.
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During the peer review process, the manufacturer of dasatinib was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflict of interest
Emma McCafferty, Sohita Dhillon and Emma Deeks are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
The manuscript was reviewed by: F. Millot, Department of Pediatric Hematology-Oncology, CIC 1402 INSERM, CHU la Milétrie, Poitiers, France; F. Mechinaud, The Royal Children’s Hospital, Melbourne, Australia.
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McCafferty, E.H., Dhillon, S. & Deeks, E.D. Dasatinib: A Review in Pediatric Chronic Myeloid Leukemia. Pediatr Drugs 20, 593–600 (2018). https://doi.org/10.1007/s40272-018-0319-8