Cancer patients with advanced hepatic impairment (HI) (ie, moderate and severe impairment) are often excluded from first-in-patient, phase II, and III studies. Thus, dose recommendations for this subgroup of patients are often derived using a combination of dedicated phase 1 studies conducted in non-cancer subjects and population pharmacokinetic (PK) modeling approach. A standardized risk-based approach to guide the evaluation of HI in cancer patients is needed. In this review, we evaluated available oncology drug approvals by the US FDA from 1999 to 2019, identified strategies utilized by sponsors to characterize the effect of HI on the PK of oncology drugs and assessed regulatory expectations for each strategy. Finally, we constructed a decision tree that complements current FDA guidance to enable efficient evaluation of HI effect on PK and provide guidance for dose recommendations.