New FDA approval for Bosulif for pediatric CML

The US Food and Drug Administration has granted a new approval for US pharma giant Pfizer’s (NYSE: PFE) hematologic malignancies drug Bosulif (bosutinib).

Bosulif is now indicated for pediatric patients one year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50mg and 100mg.

Bosulif was first approved in September 2012 in the USA for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy. It has since been cleared for a number of additional indications.