Cabometyx FDA Approval History
Last updated by Judith Stewart, BPharm on March 26, 2025.
FDA Approved: Yes (First approved April 25, 2016)
Brand name: Cabometyx
Generic name: cabozantinib
Dosage form: Tablets
Company: Exelixis, Inc.
Treatment for: Renal Cell Carcinoma, Hepatocellular Carcinoma, Thyroid Cancer, Neuroendocrine Tumors
Cabometyx (cabozantinib) is a tyrosine kinase inhibitor used for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, differentiated thyroid cancer, and neuroendocrine tumors.
- Cabometyx is 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 older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET).
- 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). - Cabometyx tablets are taken orally, once daily on an empty stomach at least 1 hour before or at least 2 hours after eating.
- Common (≥20%) adverse reactions:
- as a single agent include diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.
- in combination with nivolumab include diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
Development timeline for Cabometyx
Further information
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