Population pharmacokinetic analysis of pexidartinib in healthy subjects and patients with tenosynovial giant cell tumor or other solid tumors

O Yin, AJ Wagner, J Kang, W Knebel… - The Journal of …, 2021 - Wiley Online Library
Pexidartinib is a kinase inhibitor that induces tumor response and improvements in
symptoms and functional outcomes in adult patients with symptomatic tenosynovial giant cell …

Exposure–response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor

O Yin, H Zahir, J French, D Polhamus… - CPT …, 2021 - Wiley Online Library
This analysis was conducted to assess exposure–response relationships for efficacy and
safety of pexidartinib in patients with tenosynovial giant cell tumor. Efficacy was assessed …

Dosing recommendation based on the effects of different meal types on pexidartinib pharmacokinetics in healthy subjects: implementation of model‐informed drug …

H Zahir, O Yin, C Hsu, AJ Wagner… - Clinical …, 2023 - Wiley Online Library
Pexidartinib, an oral small molecule inhibitor of the colony‐stimulating factor 1 receptor, is
approved for treatment of adults with symptomatic tenosynovial giant cell tumor associated …

Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects

H Zahir, J Greenberg, D Shuster, C Hsu… - Clinical …, 2022 - Springer
Abstract Background and Objective Pexidartinib is a novel oral small-molecule inhibitor that
selectively targets colony-stimulating factor 1 receptor, KIT proto-oncogene receptor tyrosine …

Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure

S Nakayama, V Lukacova, S Tanabe… - Clinical …, 2024 - Wiley Online Library
Pexidartinib is a systemic treatment for patients with tenosynovial giant cell tumor not
amenable to surgery. Oral absorption of pexidartinib is affected by food; administration with …

Long‐term outcomes of pexidartinib in tenosynovial giant cell tumors

H Gelderblom, AJ Wagner, WD Tap, E Palmerini… - Cancer, 2021 - Wiley Online Library
Background The objective of this study was to report on the long‐term effects of pexidartinib
on tenosynovial giant cell tumor (TGCT). Methods This was a pooled analysis …

Development of UPLC–MS/MS method for studying the pharmacokinetic interactions of pexidartinib with antifungal drugs in rats

L Shi, Z Jiang, B Zhang, C Tang, R Xu - Journal of Pharmaceutical and …, 2020 - Elsevier
Pexidartinib was approved in the USA for targeted therapy of adult patients with symptomatic
tenosynovial giant cell tumour (TGCT) by the FDA. The purpose of our study was to develop …

Supporting patients in the transition to the revised pexidartinib dosing regimen: perspectives from the multidisciplinary clinical and allied health professional team

C McCabe, H Wright, K Polson, AJ Wagner - Orphanet Journal of Rare …, 2023 - Springer
Pexidartinib is a colony-stimulating factor-1 receptor inhibitor approved in the United States
for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) …

The challenge of drug approval in rare cancers

B Kasper - Cancer, 2021 - Wiley Online Library
Pexidartinib has emerged as a promising treatment option for patients with advanced
tenosynovial giant cell tumors and could demonstrate encouraging long‐term control in this …

Pharmacokinetics of the Multi‐kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality

H Zahir, J Greenberg, C Hsu… - Clinical …, 2023 - Wiley Online Library
Pexidartinib is an oral small‐molecule tyrosine kinase inhibitor that selectively targets colony‐
stimulating factor 1 receptor. Two phase 1 single‐center trials were conducted in healthy …