Drug · Small Molecule

Fexagratinib

CI-DRUG-00000246Explore in graph →NCIt C88272 CHEMBL3348846 CIViC Phase 2

Regulatory

Approvals (0)

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

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

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	Phase 3	Trials	Jurisdictions	First approval	First trial
All cancers	Phase3	Phase 3	3	1	15	—	—	Oct 21, 2009
Malignant Lung Neoplasm	Phase3	Phase 3	1	1	4	—	—	Jan 15, 2014
Malignant Breast Neoplasm	Phase2	Phase 2	2	0	2	—	—	Apr 7, 2014
Malignant Bladder Neoplasm	Phase2	Phase 2	1	0	1	—

Curated evidence

Clinical evidence (11)

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

civicCuratedShowing 1–11 of 11 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
FGFR1 Fusion1
Fexagratinib	Carcinoma

Clinical trials

Trials with this intervention (16)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–16 of 16 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
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Aug 28, 2026	clinicaltrials
NCT02664935	National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer	completed

TACC3 Fusion3
Fexagratinib	Cervical Squamous Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	submitted	EID9241 Phase II study (NCT02465060) from NCI-MATCH Trial (EAY131) Subprotocol W addressed the use of AZD4547 (an FGFR 1-3 inhibitor) in 48 tumor patients carrying FGFR 1-3 variants. Partial responses were ob… (full text at CIViC) PMID 32463741 · Chae et al., 2020 · Open in CIViC	civic
〃	Diffuse AstrocytomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	submitted	EID9242 Phase II study (NCT02465060) from NCI-MATCH Trial (EAY131) Subprotocol W addressed the use of AZD4547 (an FGFR 1-3 inhibitor) in 48 tumor patients carrying FGFR 1-3 variants. Partial responses were ob… (full text at CIViC) PMID 32463741 · Chae et al., 2020 · Open in CIViC	civic
〃	Renal Pelvis Urothelial CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	1	submitted	EID9227 Phase II study (NCT02465060) from NCI-MATCH Trial (EAY131) Subprotocol W addressed the use of AZD4547 (an FGFR 1-3 inhibitor) in 48 tumor patients carrying FGFR 1-3 variants. Partial responses were ob… (full text at CIViC) PMID 32463741 · Chae et al., 2020 · Open in CIViC	civic

TACC3 Fusion3

Fexagratinib

Cervical Squamous Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID9241

Phase II study (NCT02465060) from NCI-MATCH Trial (EAY131) Subprotocol W addressed the use of AZD4547 (an FGFR 1-3 inhibitor) in 48 tumor patients carrying FGFR 1-3 variants. Partial responses were ob… (full text at CIViC)

PMID 32463741 · Chae et al., 2020 · Open in CIViC

civic

〃

Diffuse AstrocytomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID9242

PMID 32463741 · Chae et al., 2020 · Open in CIViC

civic

〃

Renal Pelvis Urothelial CarcinomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID9227

PMID 32463741 · Chae et al., 2020 · Open in CIViC

civic

FGFR2 Amplification1
Fexagratinib	Gastric CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID1990 Nine patients with FGFR2-amplified gastroesophageal cancer were treated with AZD4547. Of these 9 patients, 3 showed confirmed responses to AZD4547. Median progression-free survival was 6.6 months (ra… (full text at CIViC) PMID 27179038 · Pearson et al., 2016 · Open in CIViC	civic

FGFR2 Amplification1

Fexagratinib

Gastric CarcinomaALIAS

Predictive

Supports Sensitivity Response

accepted

EID1990

Nine patients with FGFR2-amplified gastroesophageal cancer were treated with AZD4547. Of these 9 patients, 3 showed confirmed responses to AZD4547. Median progression-free survival was 6.6 months (ra… (full text at CIViC)

PMID 27179038 · Pearson et al., 2016 · Open in CIViC

civic

FGFR4 Overexpression1
Erlotinib + FexagratinibCombination	Lung Adenocarcinoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID7521 In a xenograft model, FGFR4 overexpressing HCC827 cells exhibited higher resistance to erlotinib. And also, H1975 cells showed resistance to erlotinib. The combination of erlotinib and FGFR1/2/3/4 inh… (full text at CIViC) PMID 31027687 · Quintanal-Villalonga et al., 2019 · Open in CIViC	civic

FGFR4 Overexpression1

Erlotinib + FexagratinibCombination

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID7521

In a xenograft model, FGFR4 overexpressing HCC827 cells exhibited higher resistance to erlotinib. And also, H1975 cells showed resistance to erlotinib. The combination of erlotinib and FGFR1/2/3/4 inh… (full text at CIViC)

PMID 31027687 · Quintanal-Villalonga et al., 2019 · Open in CIViC

civic

FGFR1 Overexpression1
Fexagratinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID7952 Study of FGFR1 inhibitor AZD4547 in NSCLC xenograft models. FGFR1-amplified models that overexpress FGFR1 (detected by IHC) were strongly inhibited by 25mg/kg AZH4547 (P≤0.0001). Another FGFR1-ampli… (full text at CIViC) PMID 23082000 · Zhang et al., 2012 · Open in CIViC	civic

FGFR1 Overexpression1

Fexagratinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID7952

Study of FGFR1 inhibitor AZD4547 in NSCLC xenograft models. FGFR1-amplified models that overexpress FGFR1 (detected by IHC) were strongly inhibited by 25mg/kg AZH4547 (P≤0.0001). Another FGFR1-ampli… (full text at CIViC)

PMID 23082000 · Zhang et al., 2012 · Open in CIViC

civic

FGFR1 Amplification + FGFR2 Amplification + FGFR2 Mutation + FGFR3 Mutation + FGFR3 Fusion + FGFR1 FusionFGFR1 FGFR2 FGFR31
Fexagratinib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11675 In this NCI-MATCH trial subprotocol W, 48 patients harbouring FGFR1 or FGFR2 amplification (n = 20), FGFR2 or FGFR3 single-nucleotide variants (n=19), or FGFR1 or FGFR3 fusions (n=9) were treated with… (full text at CIViC) PMID 32463741 · Chae et al., 2020 · Open in CIViC	civic

FGFR1 Amplification + FGFR2 Amplification + FGFR2 Mutation + FGFR3 Mutation + FGFR3 Fusion + FGFR1 FusionFGFR1 FGFR2 FGFR31

Fexagratinib

Malignant NeoplasmALIAS

Predictive

Does Not Support Sensitivity Response

submitted

EID11675

In this NCI-MATCH trial subprotocol W, 48 patients harbouring FGFR1 or FGFR2 amplification (n = 20), FGFR2 or FGFR3 single-nucleotide variants (n=19), or FGFR1 or FGFR3 fusions (n=9) were treated with… (full text at CIViC)

PMID 32463741 · Chae et al., 2020 · Open in CIViC

civic

FGFR3 V555M1
AZ12908010 + Fexagratinib + PD173074Substitutes	Myeloid Neoplasm	Predictive	D	Supports Resistance	2	accepted	EID6408 Preclinical study of FGFR Inhibitors AZ12908010, PD173074 and AZD4547 in cancer cell lines. Cell lines with aberrant FGFR signalling were more sensitive to FGFR Inhibition. Sequencing of a myeloma cel… (full text at CIViC) PMID 22869148 · Chell et al., 2013 · Open in CIViC	civic

FGFR3 V555M1

AZ12908010 + Fexagratinib + PD173074Substitutes

Myeloid Neoplasm

Predictive

Supports Resistance

accepted

EID6408

Preclinical study of FGFR Inhibitors AZ12908010, PD173074 and AZD4547 in cancer cell lines. Cell lines with aberrant FGFR signalling were more sensitive to FGFR Inhibition. Sequencing of a myeloma cel… (full text at CIViC)

PMID 22869148 · Chell et al., 2013 · Open in CIViC

civic

FGFR1 Expression1
Fexagratinib + FGF/VEGF Receptor Tyrosine Kinase Inhibitor, PD173074 + InfigratinibSubstitutes	Sarcoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID2915 Targeting of FGFR1 by RNA interference and small-molecule inhibitors (PD173074, AZD4547, BGJ398) revealed that the requirement for FGFR1 signaling in STS cells is dictated by FGFR1 expression levels, … (full text at CIViC) PMID 27535980 · Chudasama et al., 2017 · Open in CIViC	civic

FGFR1 Expression1

Fexagratinib + FGF/VEGF Receptor Tyrosine Kinase Inhibitor, PD173074 + InfigratinibSubstitutes

Sarcoma

Predictive

Supports Sensitivity Response

accepted

EID2915

Targeting of FGFR1 by RNA interference and small-molecule inhibitors (PD173074, AZD4547, BGJ398) revealed that the requirement for FGFR1 signaling in STS cells is dictated by FGFR1 expression levels, … (full text at CIViC)

PMID 27535980 · Chudasama et al., 2017 · Open in CIViC

civic

FGFR1 Amplification1
Fexagratinib	HER2 Negative Breast CancerUNRESOLVED	Predictive	C	Supports Sensitivity Response	2	accepted	EID1991 Eight patients with advanced HER2-negative breast cancer and FGFR1 amplification were evaluated for response to AZD4547. One patient (12.4%) demonstrated a confirmed response to AZD4547. In a preclini… (full text at CIViC) PMID 27179038 · Pearson et al., 2016 · Open in CIViC	civic

FGFR1 Amplification1

Fexagratinib

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID1991

Eight patients with advanced HER2-negative breast cancer and FGFR1 amplification were evaluated for response to AZD4547. One patient (12.4%) demonstrated a confirmed response to AZD4547. In a preclini… (full text at CIViC)

PMID 27179038 · Pearson et al., 2016 · Open in CIViC

civic