The US Food and Drug Administration (FDA) has approved Bosulif (bosutinib) for the treatment of patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy. Previously, the treatment was only approved for adults with newly diagnosed CP Ph+ CML.
The new approval was based on data from the single-arm, open-label, phase 1/2 BCHILD trial (ClinicalTrials.gov Identifier: NCT04258943). The trial was designed to identify the recommended dose of bosutinib in pediatric patients with newly diagnosed CP Ph+ CML and resistant or intolerant CP Ph+ CML who received at least 1 prior tyrosine kinase inhibitor therapy.
The trial included 28 patients with resistant or intolerant CP Ph+ CML who received bosutinib at 300 mg/m2 to 400 mg/m2 orally once daily and 21 patients with newly diagnosed CP Ph+ CML who received bosutinib at 300 mg/m2 orally once daily.
Among patients with newly diagnosed CP Ph+ CML, the major cytogenetic response (MCyR) rate was 76.2%, the complete cytogenetic response (CCyR) rate was 71.4%, and the major molecular response (MMR) rate was 28.6%.
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Among patients with resistant or intolerant CP Ph+ CML, the MCyR was 82.1%, the CCyR was 78.6%, and the MMR was 50%. Of the 14 patients in this group who achieved MMR, 2 patients lost MMR after 13.6 months and 24.7 months of treatment.
The most common adverse reactions reported in this study were diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Laboratory abnormalities included increased creatinine, increased ALT/AST, decreased white blood cell count, and decreased platelet count.
Bosulif is supplied in a new capsule dosage form in 50 mg and 100 mg strengths. For those who have difficulty swallowing the capsules, the contents can be mixed with applesauce or yogurt. Bosulif is also supplied as 100 mg, 400 mg, and 500 mg strength tablets.
References
1. FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia. News release. US Food and Drug Administration. September 27, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-bosutinib-pediatric-patients-chronic-myelogenous-leukemia.
2. Bosulif. Package insert. Pfizer; 2023. Accessed September 27, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf.
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