Drug · Small Molecule

Vandetanib

CI-DRUG-00000632Explore in graph →NCIt C2737 CHEMBL24828 CIViC Approved

Regulatory

Approvals (6)

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

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-03-07 (see label)	approved	Mar 7, 2024	openfda
US FDA	—	Efficacy supplement 2018-10-12 (see label)	approved	Oct 12, 2018	openfda
US FDA	Thyroid Gland Medullary Carcinoma	CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )	approved	Apr 6, 2011	openfda

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 14 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	3	1	9	97	6	CA, EU, US	Apr 6, 2011	2002-05
Malignant Thyroid Gland Neoplasm	Approved	Phase 4	2	1	4	12	2	EU, US	Apr 6, 2011	2004-11
Malignant Lung Neoplasm	Phase3	Phase 3	0	0	4	24	0	—	—	2002-10
Malignant Breast Neoplasm	Phase2	Phase 2	1	0	0	7	0

Curated evidence

Clinical evidence (10)

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

civicCuratedShowing 1–10 of 10 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
SDHB Mutation1
Metformin + Vandetanib

Clinical trials

Trials with this intervention (99)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–99 of 99 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
NCT00777179	Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy	completed	Phase 2	117	Genzyme, a Sanofi CompanyINDUSTRY	1	Oct 10, 2016	clinicaltrials
NCT00862836	Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)(ZACFAST)

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase SRC inhibitor; Tyrosine-protein kinase BRK inhibitor; Tyrosine-protein kinase TIE-2 inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; Ephrin receptor inhibitor; Epidermal growth factor receptor inhibitor
Targets: 25 genes
UNII: YO460OQ37K
Aliases: AZD 6474, AZD6474, Caprelsa, GNF-PF-2188, Lucivand, NSC-744325, NSC-760766, Vandetanib, Zactima, ZD-64, ZD-6474, ZD6474

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (7)

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

System	Code	Label
ATC (WHO)	L01EX04	VANDETANIB
ATC (WHO)	L01XE	Antineoplastic and immunomodulating agents

AKT2 Amplification1
Everolimus + VandetanibCombination	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	1	accepted	EID1621 Case report of a 74-year old woman with EGFR- and ALK-negative lung adenocarcinoma. FISH identified a deletion of 5'RET (FISH, indicating RET-gene rearrangement) and genomic testing confirmed a fusion… (full text at CIViC) PMID 25982012 · Subbiah et al., 2015 · Open in CIViC	civic

AKT2 Amplification1

Everolimus + VandetanibCombination

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1621

Case report of a 74-year old woman with EGFR- and ALK-negative lung adenocarcinoma. FISH identified a deletion of 5'RET (FISH, indicating RET-gene rearrangement) and genomic testing confirmed a fusion… (full text at CIViC)

PMID 25982012 · Subbiah et al., 2015 · Open in CIViC

civic

RET Fusion2
Everolimus + VandetanibCombination	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1622 Case report of a 74-year old woman with EGFR- and ALK-negative lung adenocarcinoma. FISH identified a deletion of 5'RET (FISH, indicating RET-gene rearrangement) and genomic testing confirmed a fusion… (full text at CIViC) PMID 25982012 · Subbiah et al., 2015 · Open in CIViC	civic
Vandetanib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID698 A case study of a patient with EGFR, KRAS, BRAF, HER2, ALK, ROS1 and MET negative adenocarcinoma of the lung. FISH analysis revealed a KIF5B-RET fusion. The RET inhibitor Vandetanib led to remission i… (full text at CIViC) PMID 23584301 · Gautschi et al., 2013 · Open in CIViC	civic

RET Fusion2

Everolimus + VandetanibCombination

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1622

PMID 25982012 · Subbiah et al., 2015 · Open in CIViC

civic

Vandetanib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID698

A case study of a patient with EGFR, KRAS, BRAF, HER2, ALK, ROS1 and MET negative adenocarcinoma of the lung. FISH analysis revealed a KIF5B-RET fusion. The RET inhibitor Vandetanib led to remission i… (full text at CIViC)

PMID 23584301 · Gautschi et al., 2013 · Open in CIViC

civic

RET Fusion + RET G810A1
Vandetanib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	submitted	EID4852 We established inducible KIF5B-RET transgenic mice and KIF5B-RET-dependent cell lines for preclinical modeling of KIF5B-RET-associated lung adenocarcinoma. By culturing cells with increasing concentra… (full text at CIViC) PMID 27496134 · Huang et al., 2016 · Open in CIViC	civic

RET Fusion + RET G810A1

Vandetanib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Does Not Support Resistance

submitted

EID4852

We established inducible KIF5B-RET transgenic mice and KIF5B-RET-dependent cell lines for preclinical modeling of KIF5B-RET-associated lung adenocarcinoma. By culturing cells with increasing concentra… (full text at CIViC)

PMID 27496134 · Huang et al., 2016 · Open in CIViC

civic

RET Fusion2
Vandetanib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4848 RET rearrangements involving RET are found in about 1% of NSCLC and define a unique molecular subset. This study was a multi-center, open-label, phase II clinical trial to examine the safety and effi… (full text at CIViC) PMID 27803005 · Lee et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4849 We aimed to assess the efficacy and safety of vandetanib in patients with advanced RET-rearranged NSCLC. In this open-label, multicentre, phase 2 trial (LURET), patients with advanced RET-rearranged N… (full text at CIViC) PMID 27825616 · Yoh et al., 2017 · Open in CIViC	civic

RET Fusion2

Vandetanib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID4848

RET rearrangements involving RET are found in about 1% of NSCLC and define a unique molecular subset. This study was a multi-center, open-label, phase II clinical trial to examine the safety and effi… (full text at CIViC)

PMID 27803005 · Lee et al., 2017 · Open in CIViC

civic

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID4849

We aimed to assess the efficacy and safety of vandetanib in patients with advanced RET-rearranged NSCLC. In this open-label, multicentre, phase 2 trial (LURET), patients with advanced RET-rearranged N… (full text at CIViC)

PMID 27825616 · Yoh et al., 2017 · Open in CIViC

civic

RET Overexpression2
Vandetanib	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	2	accepted	EID740 Vandetanib was tested in 4 murine models of patient-derived xenografts. In xenografts with high expression of EGFR or RET, vandetanib led to tumor regression, in those without high expression, vandeta… (full text at CIViC) PMID 26686064 · Hatem et al., 2016 · Open in CIViC	civic
〃	Estrogen Receptor-negative Breast CancerUNRESOLVED	Predictive	D	Supports Sensitivity Response	3	submitted	EID2992 The activity of Vandetanib was tested in vivo in three PDX models of TNBC and one model of HER2+ BC with different expression levels of RET and EGFR. Vandetanib induced tumor regression in PDX models … (full text at CIViC) PMID 26686064 · Hatem et al., 2016 · Open in CIViC	civic

RET Overexpression2

Vandetanib

Malignant Breast Neoplasm

Predictive

Supports Sensitivity Response

accepted

EID740

Vandetanib was tested in 4 murine models of patient-derived xenografts. In xenografts with high expression of EGFR or RET, vandetanib led to tumor regression, in those without high expression, vandeta… (full text at CIViC)

PMID 26686064 · Hatem et al., 2016 · Open in CIViC

civic

〃

Estrogen Receptor-negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID2992

The activity of Vandetanib was tested in vivo in three PDX models of TNBC and one model of HER2+ BC with different expression levels of RET and EGFR. Vandetanib induced tumor regression in PDX models … (full text at CIViC)

PMID 26686064 · Hatem et al., 2016 · Open in CIViC

civic

PDGFRB Fusion1
Erlotinib + Gefitinib + Ibrutinib + VandetanibSubstitutes	T Acute Lymphoblastic LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	submitted	EID13006 Ba/F3 cells with AGGF1:PDGFRb showed IL3 independent growth. Patient derived cells and Ba/F3, both with AGGF1:PDGFRb, were treated with erlotinib, gefitinib, ibrutinib, and vandetanib. IC50 for inhibi… (full text at CIViC) PMID 29284681 · Zabriskie et al., 2018 · Open in CIViC	civic

PDGFRB Fusion1

Erlotinib + Gefitinib + Ibrutinib + VandetanibSubstitutes

T Acute Lymphoblastic LeukemiaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

submitted

EID13006

Ba/F3 cells with AGGF1:PDGFRb showed IL3 independent growth. Patient derived cells and Ba/F3, both with AGGF1:PDGFRb, were treated with erlotinib, gefitinib, ibrutinib, and vandetanib. IC50 for inhibi… (full text at CIViC)

PMID 29284681 · Zabriskie et al., 2018 · Open in CIViC

civic