Cabometyx FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 22, 2021.
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
Cabometyx (cabozantinib) is a tyrosine kinase inhibitor used for the treatment of advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and differentiated thyroid cancer (DTC).
- 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.
- Cabometyx tablets are taken orally, once daily.
- Common side effects include diarrhea, fatigue, Palmar-Plantar Erythrodysesthesia (PPE), decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation.
Development Timeline for Cabometyx
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