Case reports show successful fatherhood and fertility preservation in males with chronic myeloid leukemia on olverembatinib, indicating reproductive safety of 3G TKIs.
As life expectancy in patients with chronic myeloid leukemia (CML) approaches that of the general population, fertility preservation has become a critical quality-of-life consideration, especially for younger patients. Although third-generation (3G) tyrosine kinase inhibitors (TKIs), such as olverembatinib, demonstrate potent efficacy against TKI-resistant disease, their reproductive safety profiles remain largely undefined. We report two TKI-resistant male patients who achieved sustained deep molecular responses with olverembatinib and who subsequently conceived healthy offspring with their partners. These cases provide clinical evidence that olverembatinib exposure does not preclude normal male fertility or healthy offspring, emphasizing the need for systematic reproductive safety data on 3G TKIs.
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Yu et al. (2025) studied this question.
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