NDAORALTABLETPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
6/8 — Strong
Priority Review
LYTGOBI (futibatinib) by Taiho Oncology is fibroblast growth factor receptor inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2022.
Drug data last refreshed 7h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYTGOBI (futibatinib) is an oral fibroblast growth factor receptor (FGFR) inhibitor developed by Taiho Oncology for oncology indications. It works by inhibiting kinase activity to suppress tumor growth driven by FGFR pathway alterations. The drug was approved in September 2022 and represents a targeted therapy for patients with specific FGFR-driven cancers.
$0.007BPart D
Peak13.0 years to LOEEarly-stage peak revenues with modest uptake suggest growth opportunity; brand team likely scaling but not yet fully staffed as with mature franchises.
Mechanism of Action
Fibroblast Growth Factor Receptor Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
Started Jun 2026
784 enrolled
Biliary Tract Cancer
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
Started Oct 2024
15 enrolled
Advanced/Metastatic Cancer
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Started Jul 2023
53 enrolled
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerEsophageal AdenocarcinomaEsophageal Squamous Cell Cancer+2 more
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Started Jul 2023
120 enrolled
Advanced CholangiocarcinomaFGFR2 FusionsGene Rearrangement
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
Started Sep 2021
38 enrolled
Advanced or Metastatic Solid Tumors Irrespective of Gene AlterationsNon-Small Cell Lung CancerKRAS Gene Mutation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.