Posted from: Tuesday, January 16, 2018 - 12:45 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Monday, October 14, 2019 - 09:21 AM.