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Effects of a High‐Fat Meal on the Pharmacokinetics of Olverembatinib in Patients With Chronic Myeloid Leukemia

Year: 2026

Type: article

Abstract: ABSTRACT Olverembatinib is approved in China to treat patients with chronic‐ or accelerated‐phase chronic myeloid leukemia (CML‐CP or CML‐AP) with T315I mutations and CML‐CP that is resistant and/or intolerant to first‐ and second‐generation tyrosine kinase inhibitors. The objective of this study was to determine the effects of a high‐fat meal on the pharmacokinetics of olverembatinib in patients with CML. Twelve participants were enrolled and received olverembatinib treatment over two periods, with a washout of 7 days between consecutive doses. Pharmacokinetics and safety were assessed in all participants. When olverembatinib was administered with a high‐fat meal, the maximum plasma concentration ( C max ) and area under the plasma concentration versus time curve from time 0 to infinity (AUC 0–∞ ) of olverembatinib increased by 105.74% and 69.74%, respectively, compared to fasting conditions. The median time to maximum plasma concentration ( T max ) of olverembatinib was not affected when it was administered with a high‐fat meal, and the geometric mean terminal plasma half‐life ( t 1/2 ) was comparable between high‐fat meal and preprandial conditions (26.8 vs. 31.1 h). The safety profile of olverembatinib was consistent with observations from previous studies; all treatment‐related adverse events were mild, and no serious adverse event was reported. These results indicate that consumption of a high‐fat meal 30 min before administering olverembatinib can increase its plasma exposure to some extent.

Source: Clinical and Translational Science

DOI: 10.1111/cts.70545