Lenvima
An oral targeted therapy used to treat kidney, thyroid, and liver cancers.
Where Lenvatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Lenvatinib was the US, on 13 Feb 2015. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of hepatocellular carcinoma (19 Mar 2015, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Lenvatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lenvatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 9 listed patents; the last listed expires 15 Nov 2038 (US 12226409, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 26 Feb 2036 (US 11186547, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 3 Oct 2027.
- Exclusivity M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection, until 3 Apr 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lenvatinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Lenvatinib works
All drug targets →- Vascular endothelial growth factor receptor inhibitor InhibitorTarget: Vascular endothelial growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- CancerPhase 3
- Carcinoma of esophagusPhase 3
- CholangiocarcinomaPhase 3
- Clear cell renal carcinomaPhase 3
- Colorectal cancerPhase 3
- Endometrial cancerPhase 3
- Endometrial carcinomaPhase 3
- Esophageal squamous cell carcinomaPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Hepatocellular carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1289601, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7426, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Lenvatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Lenvatinib. 4 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lenvatinib with pembrolizumab for untreated advanced renal cell carcinoma NICE TA858 | Optimised | 11 Jan 2023 | Current |
| Lenvatinib for untreated advanced hepatocellular carcinoma NICE TA551 | Optimised | 19 Dec 2018 | Current |
| Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine NICE TA535 | Optimised | 8 Aug 2018 | Current |
| Lenvatinib with everolimus for previously treated advanced renal cell carcinoma NICE TA498 | Recommended | 24 Jan 2018 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Lenvatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 10 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Lenvatinib
- ATC code
- L01XE29
- ChEMBL
- CHEMBL1289601
- DrugBank
- DB09078
- PubChem CID
- 9823820
- CAS number
- 417716-92-8
- FDA UNII
- EE083865G2
- Wikidata
- Q6523413
- Wikipedia
- Lenvatinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Lenvima is used for
LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). ( 1.1 ) Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. ( 1.2 ) Hepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). ( 1.3 ) Endometrial Carcinoma (EC) In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite inst…
How it works
12.1 Mechanism of Action Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; platelet derived growth factor receptor alpha (PDGFRA), KIT, and RET. Lenvatinib also exhibited antiproliferative activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling with a concurrent inhibition of FGF-receptor substrate 2 a…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.