Pexidartinib

(Turalio®)

Pexidartinib

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Drug updated on 4/18/2024

Dosage FormCapsule (oral; 125 mg)
Drug ClassKinase 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.

Summary
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  • Turalio (Pexidartinib) is 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. It demonstrates a modest improvement in pain relief over placebo, significant enhancements in physical function and stiffness, and exhibits a robust tumor response.
  • The insights were derived from four Randomized Controlled Trials that provide insights into Turalio's safety, effectiveness, and comparative positioning relative to placebo or the absence of an alternative systemic therapy for TGCT.
  • One study demonstrates a critical correlation between tumor size reduction and improvement in pain scores, suggesting Turalio's benefits may be closely tied to its effectiveness in reducing tumor burden.
  • Sustained beneficial effects on physical function and reduction in stiffness underscore Turalio's potential to enhance the quality of life for TGCT patients who cannot undergo surgery.
  • A population pharmacokinetic analysis reveals modest differences based on demographic factors such as race, sex, body weight, etc., implying stability across various patient subgroups.
  • While the drug has shown a significantly higher response rate compared to placebo, hepatotoxicity has been identified as a major concern regarding the drug’s safety profile, necessitating vigilant monitoring.

Product Monograph / Prescribing Information

Document TitleYearSource
Turalio (pexidartinib) Prescribing Information.2023Daiichi Sankyo Inc., Basking Ridge, NJ

Randomized Controlled Trials


Sex Distribution:

F:59%
M:41%
120Subjects

Year:

2023

Source:Clinical Orthopaedics and Related Research


Sex Distribution:

F:38%
M:62%
375Subjects

Year:

2021

Source:Journal of Clinical Pharmacology


Sex Distribution:

F:51%
M:49%
120Subjects

Year:

2019

Source:The Lancet