Futibatinib
Orphan DrugFDA Approved
Description
Futibatinib is an oral irreversible FGFR1-4 inhibitor approved for previously treated unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements. It is a precision-oncology orphan therapy with a narrow biomarker-defined population. This makes it a strong fit for rare-disease and specialty-access datasets.
Indications & Therapeutic Use
intrahepatic cholangiocarcinoma with FGFR2 fusion or rearrangement
Global Availability (2 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| — | — | — | — | |
| — | — | — | — |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Futibatinib
| Generic Name | futibatinib |
| Brands | 1 brand available |
| Active Ingredient | futibatinib |
| Drug Class | intrahepatic cholangiocarcinoma with FGFR2 fusion or rearrangement |
| Manufacturer | Taiho Oncology |
| Dosage Forms | Oral tablet |
| Medical Code | L01EN |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Reg. Status | FDA Approved |
| Clinical Trial | NCT02052778 |
| Countries | 2 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations3 Validated Nodes