Overview
Futibatinib is an inhibitor of Fibroblast Growth Factor receptor (FGFR), which comprises a group of receptor tyrosine kinases that play a key role in cell proliferation, differentiation, migration, and survival. FGFR was investigated in oncology as a therapeutic target, as FGFR genomic aberrations and dysregulated FGFR signalling pathways are observed in some cancers such as cholangiocarcinoma and urothelial malignancies. As a novel inhibitor of FGFR, futibatinib was first approved by the FDA in September 2022 to treat different types of intrahepatic cholangiocarcinoma. On July 4, 2023, the European Commission granted Conditional Marketing Authorization for futibatinib for the treatment of cholangiocarcinoma.
Indication
Futibatinib is indicated to treat adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. In Europe, it is indicated in patients whose disease has progressed after at least one prior line of systemic therapy. Futibatinib is approved in the US under accelerated approval and in Europe under conditional marketing authorization. This currently approved indication is subject to change, as it may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Associated Conditions
- Locally Advanced Intrahepatic Cholangiocarcinoma
- Metastatic Intrahepatic Cholangiocarcinoma
- Unresectable Intrahepatic Cholangiocarcinoma
Research Report
Futibatinib (Lytgobi®): A Comprehensive Monograph
1. Introduction to Futibatinib (Lytgobi®)
1.1. Overview and Therapeutic Class
Futibatinib is an orally administered, potent, and selective kinase inhibitor.[1] It belongs to the therapeutic class of Fibroblast Growth Factor Receptor (FGFR) inhibitors. FGFRs are a family of receptor tyrosine kinases that play a pivotal role in normal cellular physiology, including cell proliferation, differentiation, migration, and survival. However, dysregulated FGFR signaling, often driven by genomic aberrations such as gene fusions, rearrangements, mutations, or amplifications, is an established oncogenic driver in various human malignancies.[2]
Futibatinib is specifically indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions or other rearrangements.[3] This targeted indication underscores its role in precision oncology. The development and approval of futibatinib address a significant unmet medical need in this patient population, as iCCA is a rare and aggressive cancer with limited therapeutic options following progression on first-line systemic chemotherapy.
1.2. Chemical Properties and Formulation
Futibatinib is classified as a small molecule drug [User Query].
- DrugBank ID: DB15149 [User Query]
- CAS Number: 1448169-71-8 [User Query]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/09 | Phase 2 | Not yet recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | ||
2024/07/18 | Phase 2 | ENROLLING_BY_INVITATION | |||
2024/02/16 | Phase 2 | Recruiting | Yuanquan Yang | ||
2023/07/14 | Phase 2 | Active, not recruiting | |||
2023/04/25 | Phase 1 | Recruiting | |||
2023/02/14 | Phase 2 | Recruiting | |||
2022/11/14 | Phase 3 | Recruiting | |||
2021/09/08 | Phase 2 | Terminated | |||
2021/08/11 | Phase 1 | Recruiting | |||
2021/07/16 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TAIHO PHARMACEUTICAL CO., LTD. | 64842-0120 | ORAL | 4 mg in 1 1 | 2/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Taiho Pharma Netherlands B.V.,Barbara Strozzilaan 201,1083 HN Amsterdam,The Netherlands | Authorised | 7/4/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LYTGOBI futibatinib 4 mg tablet blister pack | 441350 | Medicine | A | 4/17/2025 |
Help Us Improve
Your feedback helps us provide better drug information and insights.