Overview
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs 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; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. These receptor tyrosine kinases (RTKs) located in the cell membrane play a central role in the activation of signal transduction pathways involved in the normal regulation of cellular processes, such as cell proliferation, migration, apoptosis and differentiation, and in pathogenic angiogenesis, lymphogenesis, tumour growth and cancer progression. In particular, VEGF has been identified as a crucial regulator of both physiologic and pathologic angiogenesis and increased expression of VEGF is associated with a poor prognosis in many types of cancers. Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer. Most patients with thyroid cancer have a very good prognosis with treatment (98% 5 year survival rate) involving surgery and hormone therapy. However, for patients with RAI-refractory thyroid cancer, treatment options are limited and the prognosis is poor, leading to a push for the development of more targeted therapies such as lenvatinib.
Indication
Lenvatinib is indicated for the treatment of the following cancerous conditions: Differentiated Thyroid Cancer (DTC) Renal Cell Carcinoma (RCC) Hepatocellular Carcinoma (HCC) Endometrial Carcinoma
Associated Conditions
- Advanced Renal Cell Carcinoma
- Endometrial Carcinoma
- Unresectable Hepatocellular Carcinoma (HCC)
- Progressive, locally advanced radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)
- Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/20 | Not Applicable | Not yet recruiting | |||
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/30 | Not Applicable | Not yet recruiting | |||
2025/07/22 | Not Applicable | Not yet recruiting | Wan-Guang Zhang | ||
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/02 | Not Applicable | Recruiting | |||
2025/06/10 | Phase 2 | Not yet recruiting | |||
2025/06/10 | Phase 2 | Withdrawn | |||
2025/06/08 | Phase 4 | Not yet recruiting | Fujian Medical University | ||
2025/05/23 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Eisai Inc. | 62856-704 | ORAL | 4 mg in 1 1 | 10/26/2023 | |
Eisai Inc. | 62856-720 | ORAL | 10 mg in 1 1 | 10/26/2023 | |
Eisai Inc. | 62856-712 | ORAL | 4 mg in 1 1 | 10/26/2023 | |
Eisai Inc. | 62856-710 | ORAL | 10 mg in 1 1 | 10/26/2023 | |
Eisai Inc. | 62856-708 | ORAL | 4 mg in 1 1 | 10/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 8/25/2016 | ||
Authorised | 5/28/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
LENVIMA HARD CAPSULES 10 MG | SIN14983P | CAPSULE | 10.0 mg | 4/7/2016 | |
LENVIMA HARD CAPSULE 4MG | SIN14982P | CAPSULE | 4.0 mg | 4/7/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
LENVIMA lenvatinib 4mg hard capsule blister pack | 233425 | Medicine | A | 1/28/2016 | |
LENVIMA lenvatinib 10mg hard capsule blister pack | 233426 | Medicine | A | 1/28/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
LENVIMA 4 MG CAPSULAS DURAS | 1151002001 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
LENVIMA 10 MG CAPSULAS DURAS | 1151002002 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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