Drug · Small Molecule

Cabozantinib

CI-DRUG-00000131Explore in graph →NCIt C52200 CHEMBL2105717 CIViC Approved

Regulatory

Approvals (20)

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

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Renal Cell Carcinoma	Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 13 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 4	104	50	28	239	20	CA, EU, US	Nov 29, 2012	2005-09
Malignant Kidney Neoplasm	Approved	Phase 4	42	20	13	65	3	EU, US	Apr 25, 2016	2010-04
Malignant Liver Neoplasm	Approved	Phase 3	15	8	3	30	1	US	Apr 25, 2016	Oct 30, 2012
Malignant Thyroid Gland Neoplasm	Approved	Phase 4	7	2	4	17

Curated evidence

Clinical evidence (19)

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

civicCuratedShowing 1–19 of 19 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
MET Amplification1
Cabozantinib	Gastric Adenocarcinoma

Clinical trials

Trials with this intervention (246)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–200 of 246 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
NCT06535737	A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab(CPAB)	not yet recruiting	Phase 2	40	Chulalongkorn UniversityOTHER	0	Aug 2, 2024	clinicaltrials
NCT05265988	Multiparametric Assessment of Bone Response in mCRPC Patients Treated With Cabozantinib

Molecule

Record

Kind: Small Molecule
Mechanism: Vascular endothelial growth factor receptor 2 inhibitor; Hepatocyte growth factor receptor inhibitor
Targets: 2 genes
UNII: DR7ST46X58
Aliases: 1,1-Cyclopropanedicarboxamide, N'-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N-(4- Fluorophenyl)-, BMS-907351, BMS-907351 FREE BASE, CABOMETYX, Cabozantinib, CABOZANTINIB (BMS-907351), CABOZANTINIBCT-XL184COMETRIQXL184C3627, Cabozantinib Malate, CABOZANTINIB S-MALATE, COMETRIQ, N-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-N'-(4-fluorophenyl)cyclopropane-1,1- Dicarboxamide, XL 184, XL184, XL184,BMS-907351, XL-184 FREE BASE, XL184 FREE BASE

Data updated 16 hours agoSource updated unknown

Identifiers

Codes (10)

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

System	Code	Label
ATC (WHO)	L01EX07	CABOZANTINIB
ATC (WHO)	L01XE

MET Fusion1

Cabozantinib

Infantile FibrosarcomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID8892

We describe a novel RBPMS-MET driver fusion in association with a locally aggressive IFS-like tumor. MET functions as an oncogene and, when associated with the RNA binding protein RBPMS, forms an in-f… (full text at CIViC)

PMID 33028644 · Gupta et al., 2020 · Open in CIViC

MET Exon 14 Skipping Mutation2
Cabozantinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID11400 A 77-year-old Caucasian woman (previous smoker) was diagnosed with stage IV adenocarcinoma with pleural disease. Initial genetic testing showed wild-type EGFR and ALK. She received six cycles of carbo… (full text at CIViC) PMID 30762593 · Wang et al., 2019 · Open in CIViC	civic
Cabozantinib + CrizotinibSequential	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11410 A 77-year old woman was diagnosed with lung adenocarcinoma harboring a MET exon 14 skipping mutation after PET-CT scans showed a right upper lobe mass, right hilar enlarged lymph nodes, and multiple b… (full text at CIViC) PMID 33530219 · Qin et al., 2021 · Open in CIViC	civic

ROS1 Fusion + ROS1 G2032R2
Cabozantinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1101 Cabozantinib was assessed in the CD74-ROS1-mutant Ba/F3 cells and crizotinib-resistant patient-derived cancer cells (MGH047) harboring G2032R-mutated CD74-ROS1. It effectively inhibited the survival o… (full text at CIViC) PMID 25351743 · Katayama et al., 2015 · Open in CIViC	civic
Cabozantinib + ForetinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1249 Preclinical study analyzing the efficacy of dual ROS1/ALK and more specific ROS1 inhibitors on cell lines (Ba/F3) expressing CD74-ROS1 with and without the G2032R mutation. Selective ROS1 inhibitors r… (full text at CIViC) PMID 26372962 · Davare et al., 2015 · Open in CIViC	civic