Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 25 mg, 100 mg) |
| Drug Class | Kinase 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
- 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 Title | Year | Source |
|---|---|---|
| Truseltiq (infigratinib) Prescribing Information. | 2021 | QED Therapeutics Inc., Brisbane, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. | 108Subjects F: 62% M: 38% | 2021 | The Lancet Gastroenterology & Hepatology |
| Phase II study of BGJ398 in patients with FGFR-altered cholangiocarcinoma. | 61Subjects F: 57% M: 43% | 2018 | Journal of Clinical Oncology |
Sex Distribution:
F:62%
M:38%
108Subjects
Year:
2021
Source:The Lancet Gastroenterology & Hepatology
Sex Distribution:
F:57%
M:43%
61Subjects
Year:
2018
Source:Journal of Clinical Oncology