Chronic myeloid leukemia (CML) is a myeloid malignancy for which an established, evidence-based first-line approach exists. Early agent selection and structured molecular monitoring are central to achieving favourable outcomes.
Oral tyrosine kinase inhibitor (TKI) therapy is the standard of care for newly diagnosed CML. Several approved agents across different TKI generations are available for initial therapy — the selection criteria, specific agent, and follow-up algorithm are detailed in the full protocol.
Treatment response is tracked by BCR::ABL1IS at defined time points:
These milestones reflect TKI efficacy and guide decisions on whether to continue or switch therapy; they are distinct from tolerability-driven changes.
DOI: 10.1038/s41375-025-02664-w
Six TKI are currently approved for first-line therapy, the first generation TKI imatinib, three 2GTKI, dasatinib, nilotinib, and bosutinib, the 4th generation drug, asciminib, in some countries and radotinib in South Korea.
The TKI labels recommend starting doses of imatinib of 400 mg daily, dasatinib 100 mg daily, bosutinib 400 mg daily, and nilotinib 300 mg twice daily.
In the ASC4FIRST study, 405 newly diagnosed patients were randomized to asciminib 80 mg daily or a TKI of investigators choice.
The monitoring milestones of BCR::ABL1IS at 3, 6, and 12 months specifically refer to the efficacy of the TKI and the advisability of switching treatment to achieve deeper responses: they do not address the need to change TKI because of the side effects of treatment.
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