Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 125 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Pexidartinib is the first Food and Drug Administration (FDA)-approved treatment for severe tenosynovial giant cell tumor (TGCT) in cases where surgical intervention is not an option, indicating its effectiveness for this patient population. However, specific effectiveness metrics or clinical outcomes are not detailed in the studies provided.
- The drug functions as a potent oral inhibitor of colony-stimulating factor 1 receptor (CSF-1R), and its approval suggests a positive therapeutic benefit for TGCT patients, particularly in severe cases where surgery is unfeasible, although no comparisons with other treatments or detailed outcomes are presented.
- The studies specifically focus on TGCT patients, emphasizing those with severe disease, and do not identify additional population subgroups or detailed effectiveness outcomes across different demographics.
- There is no safety information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Turalio (pexidartinib) Prescribing Information. | 2023 | Daiichi Sankyo Inc., Basking Ridge, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Update on Tenosynovial Giant Cell Tumor, an Inflammatory Arthritis With Neoplastic Features | 2022 | Frontiers in Immunology |
| Pexidartinib, a Novel Small Molecule CSF-1R Inhibitor in Use for Tenosynovial Giant Cell Tumor: A Systematic Review of Pre-Clinical and Clinical Development | 2020 | Drug Design, Development and Therapy |