CABOMETYX
CABOMETYX is a kinase inhibitor indicated for the treatment of several advanced or metastatic malignancies, including renal cell carcinoma and hepatocellular carcinoma. It is used as a first-line treatment for advanced renal cell carcinoma when administered in combination with nivolumab and as a subsequent therapy for patients with hepatocellular carcinoma previously treated with sorafenib. Additionally, the drug is approved for adult and pediatric patients aged 12 and older with specific types of differentiated thyroid cancer or well-differentiated neuroendocrine tumors that are unresectable or have progressed following prior therapies.
How CABOMETYX Works
Cabozantinib acts by inhibiting the tyrosine kinase activity of various receptors, including MET, AXL, RET, and the vascular endothelial growth factor receptors VEGFR-1, -2, and -3. These receptors are involved in essential cellular functions as well as pathologic processes such as tumor growth, metastasis, and the formation of new blood vessels. By blocking these specific pathways, the drug disrupts the maintenance of the tumor microenvironment and addresses mechanisms of drug resistance and oncogenesis.
Details
- Status
- Prescription
- First Approved
- 2016-04-25
- Routes
- ORAL
- Dosage Forms
- TABLET
CABOMETYX Approval History
What CABOMETYX Treats
5 indicationsCABOMETYX is approved for 5 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Advanced renal cell carcinoma
- Hepatocellular carcinoma previously treated with sorafenib
- Locally advanced or metastatic differentiated thyroid cancer
- Well-differentiated pancreatic neuroendocrine tumors
- Well-differentiated extra-pancreatic neuroendocrine tumors
CABOMETYX Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
CABOMETYX Competitors
Pro2 other drugs also target VEGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (VEGFR). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
CABOMETYX FDA Label Details
ProIndications & Usage
FDA Label (PDF)CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible adult and pediatric patients 12 years of age and o...
CABOMETYX Patents & Exclusivity
Patents (180 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.