FDA Approved Cabometyx
April 25, 2016 – The FDA approved Cabometyx™ (cabozantinib), manufactured by Exelixis, for the treatment of patients with advanced renal cell carcinoma (RCC). Cabometyx is for patients who have received prior anti-angiogenic therapy. This treatment interferes with several receptor tyrosine kinases, which are proteins that promote the growth and spread of tumors. Cabometyx is available in 20mg, 40mg, and 60mg tablets, and the recommended dose is 60mg once daily. In clinical trials, survival for RCC patients taking Cabometyx was about five months longer than RCC patients taking the comparator drug, Afinitor® (everolimus – Novartis). The progression-free survival rate was about twice as long (7.4 months vs. 3.8 months), and the objective response rate, a measure of tumor size decrease, was 21% for Cabometyx and 5% for Afinitor.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 1-800-332-0178
Actual drug patent expiration dates and a 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.