FDA label
What is Cabometyx used for?
Cabometyx contains cabozantinib s-malate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Cabometyx lists 4 uses: Renal Cell Carcinoma; Hepatocellular Carcinoma; Differentiated Thyroid Cancer; Neuroendocrine Tumors.
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Cabometyx, tablet
Indications and Usage, quoted from the label by Exelixis, Inc. (NDA208692). Cross-references to other label sections are left out.
Renal Cell Carcinoma
CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC.
Hepatocellular Carcinoma
CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Differentiated Thyroid Cancer
CABOMETYX is indicated for the treatment of 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.
Neuroendocrine Tumors
CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET).
CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
Source: DailyMed label, set id 3850cce2-6137-42e5-a792-d318c4a4b3b5, version 18, effective October 19, 2025. NDC 42388-023, one of 3 listings for this product.
Questions
What is Cabometyx used for?
The FDA label for Cabometyx lists 4 uses: Renal Cell Carcinoma; Hepatocellular Carcinoma; Differentiated Thyroid Cancer; Neuroendocrine Tumors.
What drug class is Cabometyx?
FDA lists cabozantinib s-malate in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Cabometyx
- Is Cabometyx a controlled substance?Federal schedule
- Generic for CabometyxFDA Orange Book
- Generic for CometriqFDA Orange Book
- Kinase Inhibitors listFDA drug class
- Cabometyx Medicare Part D coverageBy plan and state
- NDC 42388-023Cabometyx NDC record
- NDC 42388-024Cabometyx NDC record
- NDC 42388-025Cabometyx NDC record