Cabometyx Granted an Extended Indication
December 19, 2017 – The U.S. FDA has approved an extended indication for Cabometyx® (cabozantinib) tablets, manufactured by Exelixis. The product is now approved as a first-line treatment for adults who have advanced renal cell carcinoma (RCC). Initially, Cabometyx was approved for RCC only as a second-line treatment following therapy with an anti-angiogenic drug, such as Sutent® (sunitinib) or Afinitor® (everolimus).
The American Cancer Society estimated that renal cell carcinoma would account for 90% of new kidney cancer diagnoses in the United States in 2017. Patients diagnosed with RCC are most often male, and at least 45 years of age. Cabometyx is a kinase inhibitor, and works by slowing or halting the growth of cancerous tumors. Recommended dosing is 60mg daily, taken with at least eight ounces of water no less than two hours before or one hour after eating. Cabometyx tablets are available in 20mg, 40mg, and 60mg dosage forms.
The active ingredient in Cabometyx, cabozantinib, was first approved in capsule form in 2012, under the brand name Cometriq®, to treat metastatic medullary thyroid cancer (MTC). However, although Cabometyx and Cometriq contain the same active ingredient and come from the same manufacturer, they are not considered interchangeable.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.