LYTGOBI
PeakNDAORALTABLETPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
LYTGOBI by Taiho Oncology is 1, 2, 3, and 4 with ic 50 values of less than 4 nm. Approved for unresectable, locally advanced, metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (fgfr2) gene fusions and 1 more indications. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYTGOBI (futibatinib) is an oral tyrosine kinase inhibitor developed by Taiho Oncology that received FDA approval on September 30, 2022. It is indicated for unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements. Futibatinib covalently binds FGFR1, 2, 3, and 4 with IC50 values below 4 nM, inhibiting constitutive FGFR signaling that drives malignant cell proliferation and survival. The drug demonstrated anti-tumor activity in preclinical xenograft models and addresses a targeted niche within cholangiocarcinoma treatment.
$0.0BPart D
13.5 years to LOEMechanism of Action
1, 2, 3, and 4 with IC 50 values of less than 4 nM. Futibatinib covalently binds FGFR. Constitutive FGFR signaling can support the proliferation and survival of malignant cells. Futibatinib inhibited FGFR phosphorylation and downstream signaling and decreased cell viability in cancer cell lines…
Indications (4)
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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.