FDA Approves Bosutinib for Children With CML

The US Food and Drug Administration (FDA) has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who can't swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. 

Source: MEDspace