Drug · Small Molecule

Lenvatinib

CI-DRUG-00000336Explore in graph →NCIt C95124 CHEMBL1289601 CIViC Approved

Regulatory

Approvals (25)

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	Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.accelerated	approved	Aug 25, 2016	ema
EU EMA	—	Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.accelerated	approved	May 28, 2015	ema

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 16 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	168	79	58	370	25	CA, EU, US	Feb 13, 2015	2005-07
Malignant Liver Neoplasm	Approved	Phase 4	65	36	29	134	1	US	Feb 13, 2015	Jul 24, 2009
Malignant Kidney Neoplasm	Approved	Phase 4	16	6	6	31	3	EU, US	Feb 13, 2015	Aug 5, 2010
Malignant Uterine Corpus Neoplasm	Approved	Phase 3	7	3	1	11

Curated evidence

Clinical evidence (4)

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

civicCuratedShowing 1–4 of 4 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
High1
Ipilimumab + Lenvatinib

Clinical trials

Trials with this intervention (389)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 251–300 of 389 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
NCT03321630	A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies	completed	Phase 2	24	NYU Langone HealthOTHER	1	Mar 27, 2024	clinicaltrials
NCT04731740	Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: Vascular endothelial growth factor receptor inhibitor
Targets: 3 genes
UNII: EE083865G2
Aliases: 6-Quinolinecarboxamide, 4-[3-chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]- 7-methoxy-, E 7080, E-7080, E7080, ER-203492-00, Kisplyx, Lenvatinib, Lenvatinib Mesylate, LENVIMA, Multi-Kinase Inhibitor E7080

Data updated 19 hours agoSource updated unknown

Identifiers

Codes (21)

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

System	Code	Label
ATC (WHO)	L01EX08	LENVATINIB
ATC (WHO)	L01XE	Antineoplastic agents
ATC (WHO)