Open AccessTuralio risk evaluation and mitigation strategy for treatment of tenosynovial giant cell tumor: framework and experience
Author(s) -
Charles Dharmani,
Eric Wang,
Maribel Salas,
Colleen D. McCabe,
Alvileen Diggs,
Youngsook Choi,
Jason Jiang,
Vicki L. Keedy
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-1475
Subject(s) - medicine , medical prescription , clinical trial , intensive care medicine , seriousness , risk assessment , adverse effect , physical therapy , pharmacology , computer security , political science , computer science , law
For drugs with enhanced serious safety risks, Risk Evaluation and Mitigation Strategy (REMS) may be required. Pexidartinib is approved for treatment of adult symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Its approval was conditional on its prescription via a mandatory REMS due to serious and potentially fatal liver injury seen in clinical trials. Turalio ® REMS aims to mitigate this risk by ensuring provider education on pexidartinib use and required REMS components, prescriber adherence to baseline and periodic monitoring, and enrolling patients in a registry to further assess safe use and acute, chronic and irreversible hepatotoxicity. Through Turalio REMS, benefits of treating patients with pexidartinib may be preserved.