January 5th, 2018

FDA Grants Approval to Cabometyx for First-Line Treatment of Advanced Renal Cell Carcinoma

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CancerConnect News: The United States Food and Drug Administration (FDA) has approved the kinase inhibitor Cabometyx™ (cabozantinib) for the treatment of renal cell carcinoma (kidney cancer). The approval is for patients with advanced renal cell carcinoma who have already been treated with prior anti-angiogenic therapy.  The FDA previously approved Cabometyx in 2016 for treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Today’s approval provides for treatment in the first-line setting.

Each year in the United States, more than 61,000 people are diagnosed with kidney cancer. The most common type of kidney cancer is renal cell carcinoma (RCC), which starts in the lining of very small tubes (tubules) in the kidney. For people with advanced or metastatic RCC (cancer that has spread to other parts of the body), targeted therapies can play an important role in treatment. Approximately 20-30% of patients with RCC will have metastases at diagnosis and as many as 40% will demonstrate metastasis after treatment for earlier stage RCC. With a 5-year survival rate ranging from 5-10% for patients with advanced RCC, the overall prognosis for these patients is poor.

Cabometyx™ is a kinase inhibitor that stops or decreases the action of many different cellular processes involved in cancer growth or spread. Cabometyx is thought to inhibit the action of the receptor tyrosine kinases including MET, VEGFR-1, -2, and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2.

This approval was based on data from CABOSUN (NCT01835158), a comparative clinical trial performed in 157 patients with intermediate and poor-risk previously untreated RCC. Patients received Cabometyx or Sutent (sunitinin) and were directly compared. The estimated median progression-free survival for patients taking Cabometyx was 8.6 months compared with for patients taking Sutent.

Cabometyx is also approved for the treatment of medullary thyroid cancer and is marketed under the trade name Cometriq. Cometriq and Cabometyx have different formulations and are not interchangeable.

Reference:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

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Tags: Cabometyx, cabozantinib, kidney cancer, News, Renal Cancer, renal cell carcinoma, Sutent, Uncategorized