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futibatinib (Lytgobi)
Indications:
- treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Contraindications:
- pregnancy
Dosage:
- 20 mg PO QD (5 4 mg tablets)
- swallow whole with or without food
Tabs: 4 mg
Monitor:
- ophthalmoscopy including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months, & every 3 months thereafter
Adverse effects:
- common (> 20%)
- alopecia, dry eye, dry skin, nail toxicity
- palmar-plantar erythrodysesthesia syndrome
- musculoskeletal pain, abdominal pain, arthralgia
- dry mouth, stomatitis dysgeusia, decreased appetite
- nausea, vomiting, constipation, diarrhea,
- urinary tract infection
- fatigue
- laboratory abnormalities (> 20%)
- increased serum creatinine, serum creatine kinase
- increased serum ALT, serum AST, serum alkaline phosphatase, serum bilirubin
- increased activated partial thromboplastin time, international normalized ratio
- hyperglycemia, hypercalcemia, hyperphosphatemia, hypoalbuminemia
- anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia
- hyponatremnia, hypokalemia, hypoglycemia
- serious
- retinal pigment epithelium detachment
- hyperphosphatemia leading to soft tissue calcification
- embryo-fetal toxicity
Drug interactions:
- dual P-glycoprotein & g CYP3A inhibitors
- dual P-glycoprotein & g CYP3A inducers
Mechanism of action:
- futibatinib covalently binds to FGFR (FGFR1, FGFR2, FGFR3, FGFR4) & inhibits FGFR phosphorylation & downstream signaling
General
small inhibitory antineoplastic agent (ib drug)
Database Correlations
PUBCHEM correlations
References
- Goyal L, Meric-Bernstam F, Hollebecque A et al
Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma.
N Engl J Med 2023; 388:228-239
PMID: 36652354
https://www.nejm.org/doi/full/10.1056/NEJMoa2206834
- Highlights of Prescribing Information
LYTGOBI (futibatinib) tablets, for oral use
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801s000lbl.pdf