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.
- 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.