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Cabometyx Approval History

Reviewed on Apr 25, 2016 by J.Stewart BPharm.

  • FDA approved: Yes (First approved April 25th, 2016)
  • Brand name: Cabometyx
  • Generic name: cabozantinib
  • Dosage form: Tablets
  • Company: Exelixis, Inc.
  • Treatment for: Renal Cell Carcinoma

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior antiĀ­-angiogenic therapy.

The FDA approval of Cabometyx was based on results of the phase 3 METEOR trial which included 658 patients with advanced renal cell carcinoma who had failed at least one prior VEGF receptor tyrosine kinase inhibitor therapy. Patients were randomized 1:1 to receive 60 mg of Cabometyx daily or 10 mg of everolimus daily. Compared with everolimus, Cabometyx was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus.

Cabometyx tablets are taken once daily without food. Cabometyx must not be substituted for the capsule form of cabozantinib (Cometriq), which is a different formulation approved for the treatment of medullary thyroid cancer.

The most common side effects reported in clinical trials include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.

Development History and FDA Approval Process for Cabometyx

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

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