SUMMARY  

• Mild to moderate hepatic impairment (Child-Pugh Class A and B) had no clinically relevant effects on the systemic exposure of apalutamide and N-desmethyl apalutamide. No initial dosage adjustment is necessary for patients with mild to moderate hepatic impairment.¹
• No data are available in patients with severe hepatic impairment (Child-Pugh Class C).¹
• In the phase 3 SPARTAN Study and TITAN Study, eligible patients were required to have adequate hepatic function (defined as serum aspartate transaminase [AST] and serum alanine transaminase [ALT] ≤2.5x upper limit of normal [ULN], and total serum bilirubin ≤1.5x ULN).^2-5

clinical DATA

Phase 3 SPARTAN Study

In the phase 3 SPARTAN study, which evaluated the efficacy and safety of ERLEADA compared to placebo in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC; defined as prostate-specific antigen [PSA] doubling time [PSADT]
≤10 months) on continuous androgen deprivation therapy (N=1207), eligible patients were required to have adequate hepatic function, which was defined by the following criteria: serum AST and serum ALT ≤2.5x ULN, and total serum bilirubin ≤1.5x ULN.^2,3

Phase 3 TITAN Study

In the phase 3 TITAN study, which evaluated the efficacy and safety of ERLEADA compared to placebo in patients with metastatic castration-sensitive prostate cancer (mCSPC) on continuous ADT (N=1052), eligible patients were required to have adequate hepatic function, which was defined by the following criteria: serum AST and serum ALT ≤2.5x ULN, and total serum bilirubin ≤1.5x ULN.^4,5

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 28 August 2024.