A Phase I/II Study of Bosutinib in Pediatric Patients with Resistant/Intolerant or Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, Study ITCC (Innovative Therapies for Children with Cancer European Consortium) 054 and COG (Children's Oncology Group Consortium) AAML1921: Results from the Phase I Trial in Resistant/Intolerant Patients

Bosutinib is a tyrosine kinase inhibitor (TKI), approved for adults with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML); 400 mg in newly diagnosed (ND) patients (pts), and 500 mg in resistant/intolerant (R/I) pts, administered once daily (QD) with food. Its toxicity profile differs from other TKIs approved in children (imatinib, dasatinib and nilotinib), showing a higher incidence of gastrointestinal (GI) adverse events (AEs) but fewer toxicities such as musculoskeletal AEs (Cortes JE et al, 2016). Furthermore, in mice, bosutinib showed less growth impairment compared to other TKIs (Tauer JT et al, 2015).