Dasatinib real-world safety profiles in pediatric patients

A real-world study analyzing the safety data of dasatinib in pediatric patients with malignancies, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) (28.53% of cases; n = 109) and Ph+ acute lymphoblastic leukemia (ALL) (25.65% of cases; n = 98), using the Food and Drug Administration Adverse Event Reporting System (FAERS) database was published by Yang et al. in the Japanese Journal of Clinical Oncology. A total of 382 dasatinib-related events were analyzed. 

Key data: The most common dasatinib-related adverse events (AEs) by system organ class (SOC) were general disorders and administration site conditions (16%), injury, poisoning, and procedural complications (12.6%), and gastrointestinal disorders (9.1%). Hemorrhagic enterocolitis, lymphoid tissue hyperplasia, hydrocephalus, and hemorrhagic cystitis were newly identified AEs. Several growth- and development-related toxicities, including growth retardation, failure to thrive, bone pain, and bone marrow disorders, were observed. Off-label use of dasatinib for brain neoplasms and glioma was identified. 

Key learning: The study highlights safety signals of dasatinib in pediatric patients, including previously unreported AEs and growth-related toxicities. It emphasizes the importance of pharmacovigilance and risk management to guide safer prescribing practices in pediatric oncology settings.