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FDA approves Bosutinib for pediatric Chronic Myelogenous Leukemia patients
Overview
On September 26, 2023, the Food and Drug Administration (FDA) granted approval for the use of bosutinib in pediatric patients aged 1 year and older who have chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). This approval covers cases that are newly diagnosed or those that are resistant or intolerant to prior therapy. Additionally, the FDA approved a new capsule dosage form, available in 50 mg and 100 mg strengths.
The approval followed an assessment of the drug's efficacy in the BCHILD trial (NCT04258943), an open-label, multicenter study. The trial aimed to determine the recommended dose of bosutinib in pediatric patients with newly diagnosed and resistant or intolerant CP Ph+ CML. It also evaluated the drug's safety, tolerability, and pharmacokinetics in this patient population. In total, 28 patients with resistant or intolerant CP Ph+ CML and 21 patients with newly diagnosed CP Ph+ CML participated in the trial.
For pediatric patients with resistant or intolerant CP Ph+ CML, the major cytogenetic response and complete cytogenetic response rates were 82.1% and 78.6%, respectively, with an MMR rate of 50%. Among the 14 patients who achieved major molecular response MMR, two lost MMR after 13.6 and 24.7 months on treatment. The median follow-up was 23.2 months.
The most common adverse reactions in pediatric patients (≥20%) included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline (≥45%) were increased creatinine, increased alanine aminotransferase or aspartate aminotransferase, decreased white blood cell count, and decreased platelet count.
The recommended dosage for pediatric patients with newly diagnosed CP Ph+ CML is 300 mg/m2 orally once daily with food, while the recommended dose for those with resistant or intolerant CP Ph+ CML is 400 mg/m2 orally once daily with food. For patients who cannot swallow capsules, the capsule contents can be mixed with applesauce or yogurt.
Speakers
Isra Zaman
B.Sc Life Sciences, M.Sc Biotechnology, B.Ed