Cabometyx (cabozantinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2016

Specific Treatments:

advanced renal cell carcinoma

Therapeutic Areas

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General Information

Cabometyx (cabozantinib) is a kinase inhibitor.

Cabometyx is specifically indicated for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy. 

Cabometyx is supplied as tablets for oral administration The recommended dose is 60 mg orally, once daily. Patients should not to eat for at least 2 hours before and at least 1 hour after taking Cabometyx. Do not substitute Cabometyx tablets with cabozantinib capsules. 

Clinical Results

FDA Approval

The FDA approval of Cabometyx was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received either cabozantinib 60 mg orally once daily (N=330) or everolimus 10 mg orally once daily (N=328). The primary endpoint was progression-free survival among the first 375 randomized subjects. Median progression-free survival in this group was 7.4 and 3.8 months in the cabozantinib and everolimus arms, respectively (p<0.0001). Median overall survival in the intent-to-treat population was 21.4 and 16.5 months in the cabozantinib and everolimus arms, respectively (p=0.0003). Confirmed response rate was 17% in the cabozantinib arm and 3% in the everolimus arm.

Side Effects

Adverse effects associated with the use of Cabometyx may include, but are not limited to, the following:

  • diarrhea
  • fatigue
  • nausea
  • decreased appetite
  • palmar-plantar erythrodysesthesia syndrome
  • hypertension
  • vomiting
  • weight decreased
  • constipation

Mechanism of Action

Cabometyx (cabozantinib) is a kinase inhibitor.  Cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment. 

Additional Information

For additional information regarding advanced renal cell carcinoma or Cabometyx, please visit https://www.cabometyx.com/