LENVIMA
Lenvima is a kinase inhibitor indicated for the treatment of several types of advanced, recurrent, or unresectable malignancies. It is used as a monotherapy for radioactive iodine-refractory differentiated thyroid cancer and as a first-line treatment for unresectable hepatocellular carcinoma. The drug is also used in combination with other therapies, such as pembrolizumab or everolimus, to treat advanced renal cell carcinoma and specific forms of advanced endometrial carcinoma.
How LENVIMA Works
Lenvatinib inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, VEGFR2, and VEGFR3. It also targets other kinases implicated in pathogenic angiogenesis and tumor progression, including fibroblast growth factor (FGF) receptors, platelet-derived growth factor receptor alpha, KIT, and RET. By blocking these pathways, the drug inhibits endothelial cell proliferation and signaling necessary for tumor growth and blood vessel formation.
Details
- Status
- Prescription
- First Approved
- 2015-02-13
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LENVIMA Approval History
What LENVIMA Treats
5 indicationsLENVIMA is approved for 5 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
- Advanced renal cell carcinoma (first-line, in combination with pembrolizumab)
- Advanced renal cell carcinoma following one prior anti-angiogenic therapy (in combination with everolimus)
- Unresectable hepatocellular carcinoma (first-line)
- Advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) following prior systemic therapy (in combination with pembrolizumab)
LENVIMA Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
LENVIMA Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LENVIMA FDA Label Details
ProIndications & Usage
FDA Label (PDF)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). Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Hepatocellular Carcinoma (HCC) For the first-line treatm...
LENVIMA Patents & Exclusivity
Patents (84 active)
Exclusivity
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.