Futibatinib
Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitors
Sold as LYTGOBI
- Drug class
- Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Plain-language summary, compiled from the cited regulatory records
Futibatinib is a type of medication known as a Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitor [1]. It is approved for treating adult patients with intrahepatic cholangiocarcinoma that is unresectable, locally advanced, or metastatic [1]. This specific approval is for patients whose cancer has fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [1]. The indication was granted under accelerated approval, based on the overall response rate and duration of response observed in clinical studies [1].
Futibatinib is marketed under the brand name LYTGOBI [1]. Continued approval for this indication may depend on the verification of clinical benefit in confirmatory trials [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | October 27, 2025 |
| GB United Kingdom | MHRA | 1 | May 22, 2026 |
| EU European Union | EMA | 1 | October 29, 2025 |
USUnited States· FDA
1 product
Uses
1) ] . 1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor 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.
1 ) 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 verification and description of clinical benefit in a confirmatory trial(s).
( 1 )
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
How to take
EUEuropean Union· EMA
1 product
Uses
Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
How to take
Sources & citations
- [1]FDA DailyMed · 0b1332a1-0581-47… · revised October 27, 2025 [PDF]
- [2]MHRA (UK) · PLGB412250001 · revised May 22, 2026
- [3]European Medicines Agency · EMEA/H/C/005627 · revised October 29, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.