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SEPTEMBER 28, 2023

FDA Approves Bosulif for Pediatric Patients With CML

The FDA approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 and 100 mg.

Efficacy was evaluated in the BCHILD trial, a multicenter, non-randomized, open-label trial conducted to identify a recommended bosutinib dose for pediatric patients with newly