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infigratinib (Truseltiq)
Indications:
- treatment of metastatic cholangiocarcinoma with FGFR2 fusion or other gener rearrangement as detected by an FDA-approved test*
* FDA also approved companion diagnostic test for FGFR2 fusion or other rearrangement
Dosage:
- 125 mg PO QD for 21 days followed by 7 off days in 28 day cycles until disease progression or unacceptable toxicity
Tabs: 25 mg, 50 mg, 75 mg, 100 mg
Adverse effects:
- >20%
- hyperphosphatemia, increased serum creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, vision blurred, vomiting
- serious risks
- hyperphosphatemia
- retinal pigment epithelium detachment
Mechanism of action:
- inhibits FGFR with IC50 values of 1.1, 1, 2, & 61 nM for FGFR1, FGFR2, FGFR3, & FGFR4, respectively
- major human metabolites of infigratinib have similar in vitro binding affinities for FGFR1, FGFR2, & FGFR3 compared to infigratinib.
- infigratinib inhibits FGFR signaling & decreased cell proliferation in cancer cell lines with activating FGFR amplifications, mutations, or fusions
General
small inhibitory antineoplastic agent (ib drug)
References
- FDA. May 28, 2021
FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-infigratinib-metastatic-cholangiocarcinoma
- HIGHLIGHTS OF PRESCRIBING INFORMATION
TRUSELTIQ (infigratinib) capsules, for oral use
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214622s000lbl.pdf