Summary

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• Bosulif (bosutinib) is indicated for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy, and for the treatment of adult patients with accelerated or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• Major Molecular Response (MMR) Rates: Ponatinib achieved MMR rates ranging from 19.0% to 66.7%, Asciminib from 23.3% to 25.5%, Omacetaxine 19.2%, and Bosutinib 13.2% at 6 months.
• Complete Cytogenetic Response (CCyR) Rates: Ponatinib showed CCyR rates between 21.4% and 64.8%, Asciminib between 38.7% and 40.8%, Bosutinib between 18% and 24.2%, and Omacetaxine 16.1% at 6 months.
• Overall Survival (OS) and Progression-Free Survival (PFS): No significant differences in 5-year OS or PFS were observed between imatinib and nilotinib or dasatinib.
• Comparison of Effectiveness: Second and third-generation TKIs, including nilotinib, dasatinib, and bosutinib, showed improved clinical responses compared to imatinib, with higher early molecular responses. Bosutinib demonstrated lower MMR and CCyR rates compared to ponatinib and asciminib.
• Second-generation TKIs (including bosutinib) demonstrated a higher relative risk of cutaneous adverse events compared to imatinib (RR = 1.62).
• Hematological adverse events were prevalent, with dasatinib showing the highest rates of anemia (54.5%), neutropenia (51.2%), and thrombocytopenia (62.2%) among the compared TKIs.
• Bosutinib had the highest overall incidence of gastrointestinal adverse events (52.9%), with diarrhea being the most prevalent (79.2%).
• There is no population types or subgroups information available in the reviewed studies.