Posted from: Friday, December 01, 2017 - 12:47 PM - Present

New Indication for Sutent

November 16, 2017 – The U.S. FDA has approved a new indication for Sutent® (sunitinib), manufactured by Pfizer, to be used as an adjuvant therapy to prevent the recurrence of renal cell carcinoma (RCC) in adults who are at high risk of a recurrence after the removal of a cancerous kidney. A multi-kinase inhibitor, Sutent was associated with an improved average length of disease-free survival (6.8 years versus 5.6 years for patients on a placebo) in a clinical study of post-surgical RCC patients.

Recommended dosing under the new indication is cyclical. Each six-week cycle consists of four weeks taking 50mg of Sutent taken by mouth once daily, followed by two weeks spent off of the medication. Patients should complete a total of nine cycles.

Previously held indications include the treatment of gastrointestinal and pancreatic tumors, as well as advanced RCC. Sutent carries a black box warning that cautions against the risk of hepattooxicity, which can lead to fatal liver failure.

 

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 Tuesday, July 17, 2018 - 01:02 PM.