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# FDA OKs Expanded Approval for Pfizer’s Sutent
- URL: https://www.fdaweb.com/fda-oks-expanded-approval-for-pfizers-sutent/
- Published: 2017-11-16T12:00:00.000Z
- Updated: 2026-09-14T23:02:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140151

FDA has approved Pfizer’s Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. “This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” FDA Oncology Center of Excellence director **Richard Pazdur** is quoted in a [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585657.htm?ref=fdaweb.com) as saying.

Sutent is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It was first approved in 2006 for treating certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for certain pancreatic cancer patients.

The newest approval was based on data from a randomized trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. “After five years, 59.3% of patients treated with Sutent had not experienced cancer recurrence or death compared with 51.3% of patients receiving placebo,” the agency says.

Common side effects of Sutent include fatigue, diarrhea, inflammation of the mucous membranes and inside the mouth, nausea, decreased appetite/anorexia, vomiting, abdominal pain, skin reactions on the hands and feet, high blood pressure, bleeding events, altered taste, indigestion and low levels of blood platelets. Severe side effects include severe liver damage, heart failure, heart attack, abnormal health rhythm (prolonged QT intervals/Torsade de Pointes), hypertension, bleeding (hemorrhagic events), metabolic abnormalities due to breakdown of the tumor (tumor lysis syndrome), and blood vessel abnormalities leading to blood clots in the small blood vessels resulting in low platelet counts and organ dysfunction, among others, according to FDA.