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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

DateArticle
Sep 17, 2021Approval  Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Jan 22, 2021Approval  FDA Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma
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

Further information

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