Entrectinib dose confirmation in pediatric oncology patients: pharmacokinetic considerations

Overall, the F1 formulation of entrectinib was associated with lower systemic exposure in pediatric patients compared with the commercial acidulant formulation (F06). Systemic exposures achieved in pediatric patients with the F06 recommended dose (300 mg/m²) were within the known efficacious range in adults, confirming the adequacy of the recommended dose regimen with the commercial formulation.