FDA Approves Bosulif for Pediatric Ph-Positive CML

The Food and Drug Administration (FDA) approved Bosulif (bosutinib) for the treatment of children aged 1 year and older with newly diagnosed or resistant/intolerant to prior therapy chronic phase Philadelphia (Ph)-positive chronic myelogenous leukemia (CML), according to an announcement from the agency. A new capsule dosage — available in 50 mg and 100 mg strengths — was also approved.

The prescribing information states that patients should take 300 mg/m2 of Bosulif orally each day with food. For children who cannot swallow pills, the medication can be mixed with applesauce or yogurt.

The approval is based on findings from the BCHILD clinical trial that investigated the appropriate dosage and how Bosulif worked within the body for this patient population. The trial included 28 children with resistant or intolerant Ph-positive CML who were administered 300 mg/m2 to 400 mg/m2 of Bosulif, and 21 patients who were treated at 300 mg/m2.

Results from the trial showed that in the newly diagnosed population, the major cytogenetic response (meaning that 35% or fewer of the cells in the bone marrow have the Philadelphia chromosome) rate was 76.2%, while the complete cytogenetic response (meaning that no or less than 1% of cells in the bone marrow have the Philadelphia chromosome) was 71.4%. The major molecular response was 28.6%, while the median duration of follow-up was 14.2 months.

For patients with resistant or intolerant disease, the major and complete cytogenetic responses were 82.1% and 78.6%, respectively. The major molecular response for this population was 50%. Notably, among the 14 patients who had a major molecular response, two lost their response at 13.6 and 24.7 months.

The most common side effects from Bosulif that were observed in 20% or more of patients were diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, liver dysfunction, headache, fever, decreased appetite and constipation. The most common laboratory abnormalities that worsened after taking the drug and occurred in 45% or more of patients were increased creatinine, increased alanine aminotransferase or aspartate aminotransferase, decreased white blood cell count and decreased platelet count.

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