Tyrosine kinase inhibitors, chronic myeloid leukemia, and pregnancy: pharmacotherapeutic challenges and recommendations.

[INTRODUCTION] The annual incidence of Philadelphia chromosome-positive chronic myeloid leukemia (CML) is 1 per 100,000 pregnancies. The management of CML during pregnancy poses challenges due to the teratogenicity risk associated with the BCR:ABL1 tyrosine kinase inhibitors (TKIs).

[AREAS COVERED] In this review, we discuss the possible fetotoxicity of CML therapies during pregnancy, including TKIs and non TKI-based regimens and the treatment strategies for pregnant patients.

[EXPERT OPINION] The diagnosis of CML during pregnancy is rare, and evidence guiding optimal management remains limited. Current recommendations categorize treatments into TKIs and non TKI-based therapies. All TKIs are not recommended during the first trimester due to their risk of teratogenesis, but imatinib and nilotinib may be cautiously used from Weeks 16-18 onward. Non-TKI therapies, such as hydroxyurea and interferon-α, are considered safe throughout pregnancy. Data on ponatinib and asciminib remain insufficient to allow the safe use of these agents during pregnancy. Future research should aim to improve treatment-free remission rates through novel agents and combination strategies to allow a higher proportion of younger patients to discontinue therapy. Clinicians should always counsel women on pregnancy risks during therapy while reassuring male patients of TKI safety when fathering children.