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Cabometyx Approval History

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

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC), and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Development History and FDA Approval Process for Cabometyx

DateArticle
Jan 14, 2019Approval Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
Dec 19, 2017Approval Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma
Apr 26, 2016Approval Exelixis Announces FDA Approval of Cabometyx (cabozantinib) for Patients with Advanced Renal Cell Carcinoma
Feb  1, 2016Exelixis Announces Positive Overall Survival Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma
Jan 28, 2016Exelixis Announces U.S. FDA Deems NDA Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma

Further information

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