Drug · Small Molecule

Futibatinib

CI-DRUG-00000254Explore in graph →NCIt C114283 CHEMBL3701238 CIViC Approved

Regulatory

Approvals (2)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Intrahepatic Cholangiocarcinoma	LYTGOBI is 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 [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . 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 , 2.1 ) 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 )accelerated	approved	Sep 30, 2022	openfda

Data updated 12 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	12	8	5	20	2	EU, US	Sep 30, 2022	Jul 21, 2014
Malignant Liver Neoplasm	Approved	Phase 2	0	0	0	1	1	US	Sep 30, 2022	Aug 17, 2021
Malignant Esophageal Neoplasm	Phase2	Phase 2	3	1	0	3	0	—	—	Jun 1, 2021
Malignant Gastric Neoplasm	Phase2	Phase 2	2	1	0	3	0

Curated evidence

Clinical evidence (32)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–32 of 32 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FGFR2 Amplification + FGFR2 Fusion1
Futibatinib	Cholangiocarcinoma

Clinical trials

Trials with this intervention (21)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–21 of 21 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02693535	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer(TAPUR)	recruiting	Phase 2	4,200	American Society of Clinical OncologyOTHER	2	Sep 22, 2026	clinicaltrials
NCT05727176	Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Molecule

Record

Kind: Small Molecule
Mechanism: Fibroblast growth factor receptor inhibitor
Targets: 4 genes
UNII: 4B93MGE4AL
Aliases: 2-Propen-1-one, 1-((3S)-3-(4-Amino-3-(2-(3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)-1-pyrrolidinyl)-, Fgfr-in-1, Futibatinib, Lytgobi, LYTGOBI, TAS 120, TAS-120, TAS120

Data updated 15 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EN04	antineoplastic agents
EMA product	EMEA/H/C/005627	Lytgobi

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

BICC1 Fusion2
Futibatinib	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11629 In a phase 1 multihistology trial of the FGFR1/2/3/4 inhibitor futibatinib, an objective response rate of 13.7% was seen with responses in a broad spectrum of tumors and across a broad spectrum of FGF… (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic
〃	Intrahepatic Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID11610 In a phase 2 trial (NCT02052778) of the FGFR1/2/3/4 inhibitor futibatinib in 103 patients with previously treated intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, the overal… (full text at CIViC) PMID 36652354 · Goyal et al., 2023 · Open in CIViC	civic

KIAA1217 Fusion2
Futibatinib	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	1	submitted	EID11647 In a phase 1 multihistology trial of the FGFR1/2/3/4 inhibitor futibatinib, an objective response rate of 13.7% was seen with responses in a broad spectrum of tumors and across a broad spectrum of FGF… (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic
〃	Intrahepatic Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11611 In a phase 2 trial (NCT02052778) of the FGFR1/2/3/4 inhibitor futibatinib in 103 patients with previously treated intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, the overal… (full text at CIViC) PMID 36652354 · Goyal et al., 2023 · Open in CIViC	civic

FGFR2 Fusion2
Futibatinib	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	4	submitted	EID12489 The authors detail a phase 1 dose-expansion trial of a pan-FGFR inhibitor, fubatinib. Most FGFR inhibitors are reversible ATP-competitor inhibitors that tumors can acquire resistance to. Futibatinib, … (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic
〃	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID7322 Among six patients with advanced FGFR2 fusion-positive ICC who received care at our institution after progression on BGJ398 or Debio1347 in clinical trials, four subsequently enrolled in the phase I t… (full text at CIViC) PMID 31109923 · Goyal et al., 2019 · Open in CIViC	civic

FGFR2 Fusion + FGFR2 Fusion3
Futibatinib	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11632 In a phase 1 multihistology trial of the FGFR1/2/3/4 inhibitor futibatinib, an objective response rate of 13.7% was seen with responses in a broad spectrum of tumors and across a broad spectrum of FGF… (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic
〃	Intrahepatic Cholangiocarcinoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID11609 In the phase 2 trial (NCT02052778), 103 patients (22-79 years of age) with unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements were treated with the … (full text at CIViC) PMID 36652354 · Goyal et al., 2023 · Open in CIViC	civic
〃	Intrahepatic Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID11612 In a phase 2 trial (NCT02052778) of the FGFR1/2/3/4 inhibitor futibatinib in 103 patients with previously treated intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, the overal… (full text at CIViC) PMID 36652354 · Goyal et al., 2023 · Open in CIViC	civic

FGFR2 Amplification2
Futibatinib	Gastric Adenocarcinoma	Predictive	C	Supports Sensitivity Response	1	submitted	EID11637 In a phase 1 multihistology trial of the FGFR1/2/3/4 inhibitor futibatinib, an objective response rate of 13.7% was seen with responses in a broad spectrum of tumors and across a broad spectrum of FGF… (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic
〃	Triple-Negative Breast CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	2	submitted	EID11648 In a phase 1 multihistology trial of the FGFR1/2/3/4 inhibitor futibatinib, an objective response rate of 13.7% was seen with responses in a broad spectrum of tumors and across a broad spectrum of FGF… (full text at CIViC) PMID 34551969 · Meric-Bernstam et al., 2022 · Open in CIViC	civic