Substance / Medication

Futibatinib

Overview

Active Ingredient
futibatinib
RxNorm CUI
2628190

Indications

Dosage and Administration (2.1) [see] LYTGOBI is indicated for the 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. Clinical Studies (14.1) [see] This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verific

Labeler: TAIHO PHARMACEUTICAL CO., LTD.Updated: 2025-07-31T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Effect of Futibatinib on Cardiac Repolarization: Results of a Randomized, Controlled, Double-Blind, QT/QTc, Phase 1 Study in Healthy Subjects.
Yamamiya Ikuo, Lester Robert, Sonnichsen Daryl et al. · Clin Pharmacol Drug Dev · 2023
PMID: 36404525RCT
Phase 2 study of futibatinib in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplifications.
Satoh Taroh, Barthélémy Philippe, Nogova Lucia et al. · Eur J Cancer · 2025
PMID: 39919334Trial
Futibatinib for-Rearranged Intrahepatic Cholangiocarcinoma.
Goyal Lipika, Meric-Bernstam Funda, Hollebecque Antoine et al. · N Engl J Med · 2023
PMID: 36652354Trial
Evaluation of Potential Food Effects and Drug Interactions With Lansoprazole in Healthy Adult Volunteers Receiving Futibatinib.
Yamamiya Ikuo, Hunt Allen, Yamashita Fumiaki et al. · Clin Pharmacol Drug Dev · 2023
PMID: 36382853Trial
Evaluation of the Mass Balance and Metabolic Profile of Futibatinib in Healthy Participants.
Yamamiya Ikuo, Hunt Allen, Yamashita Fumiaki et al. · Clin Pharmacol Drug Dev · 2023
PMID: 37300358Trial
Futibatinib, an Irreversible FGFR1-4 Inhibitor, in Patients with Advanced Solid Tumors Harboring/Aberrations: A Phase I Dose-Expansion Study.
Meric-Bernstam Funda, Bahleda Rastislav, Hierro Cinta et al. · Cancer Discov · 2022
PMID: 34551969TrialFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Futibatinib (substance)
SNOMED CT
1351548001
UMLS CUI
C5139845
RxNorm CUI
2628190
Labeler
TAIHO PHARMACEUTICAL CO., LTD.

Clinical Data

This intervention maps to 2 entities in the Ltrl knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.