Infigratinib

(Truseltiq®)

Infigratinib

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Drug updated on 5/7/2024

Dosage FormCapsule (oral; 25 mg, 100 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Summary
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  • Infigratinib (Truseltiq) is a selective, ATP-competitive inhibitor of fibroblast growth factor receptors used for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement.
  • The information was derived from one document which is a Randomized Controlled Trial that evaluated the antitumor activity of infigratinib in patients with locally advanced or metastatic cholangiocarcinoma and FGFR2 alterations who had previous gemcitabine-based treatment.
  • This study involved 108 participants aged 18 years and older who were previously treated with at least one gemcitabine-containing regimen; they received oral doses of infigratinib once daily until disease progression, intolerance, withdrawal of consent, or death occurred.
  • After median follow-up period lasting approximately 10 months on average (IQR:6-15), it was found that about 23% patients showed objective response rate to Truseltiq as assessed by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1; this included one complete response and twenty-four partial responses among these patients.
  • Common adverse events associated with Truseltiq include hyperphosphataemia (n=83), stomatitis (n=59), fatigue (n=43), alopecia (n=41); ocular toxicity such as dry eyes also reported frequently alongwith Central serous retinopathy-like and retinal pigment epithelial detachment-like events occurring in around seventeen percent cases but no deaths related to drug administration were recorded during trial period.
  • Based on results obtained from this randomized controlled trial involving adult population suffering from advanced/metastatic cholangiocarcinoma having undergone prior gemcitabine therapy, Infigratinib (Truseltiq) shows promising clinical activity and manageable adverse event profile, thus representing a potential new therapeutic option in this setting.

Product Monograph / Prescribing Information

Document TitleYearSource
Truseltiq (infigratinib) Prescribing Information.2021QED Therapeutics Inc., Brisbane, CA

Randomized Controlled Trials


Sex Distribution:

F:57%
M:43%
61Subjects

Year:

2018

Source:Journal of Clinical Oncology