SUMMARY  

• No formal studies of TALVEY in patients with hepatic impairment have been conducted.¹
• Results of population pharmacokinetic analyses indicate that mild hepatic impairment (total bilirubin >1 to 1.5 times upper limit of normal [ULN] and any aspartate aminotransferase [AST], or total bilirubin ≤ULN and AST>ULN) or moderate hepatic impairment (total bilirubin 1.5 to 3 times ULN and any AST>ULN) did not significantly influence the pharmacokinetics of TALVEY. No data is available in patients with severe hepatic impairment.¹
• Based on population pharmacokinetic analyses, no dose adjustment is recommended for patients with mild or moderate hepatic impairment.¹
• MonumenTAL-1 (MMY1001) is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody.²
  • Per protocol, patients enrolled in the study were required to have adequate hepatic function during the screening phase described as: total bilirubin ≤2.0 × upper limit of normal (ULN), except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 × ULN was required); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3.0 × ULN.³

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 11 November 2024.