TURALIO^® Risk Evaluation and Mitigation Strategy Program (tREMS): 3-year retrospective hepatic safety assessment.

ABSTRACT: Aim: Hepatic safety data assessment from the TURALIO^® (pexidartinib) Risk Evaluation and Mitigation Strategy (tREMS) Program.Methods: Retrospective 3-year assessment (August 2019 to June 2022) of hepatic events from the TURALIO® (pexidartinib) Risk Evaluation and Mitigation Strategy Program.Results: A total of 451 patients, 369 prescribers, 2 wholesalers/distributors and 2 pharmacies were enrolled and certified. Twenty-one (4.7%) patients met the criteria for a hepatic adverse event or laboratory abnormality suggestive of serious and potentially fatal liver injury, all with onset within 2 months of therapy. No new hepatic safety signals were identified.Conclusion: Results are consistent with the phase 3 ENLIVEN trial data. Liver enzyme monitoring, com

SUBMITTER: Dharmani C 

PROVIDER: S-EPMC11534110 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature