FDA Expands Approval for Sutent (Sunitinib) After Kidney Cancer Surgery

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved Sutent (sunitinib) to treat adults who are at high risk of kidney cancer returning after they’ve had a nephrectomy, surgical removal of a kidney. Treatment to lower the chance of cancer recurring is called adjuvant treatment. The FDA previously approved Sutent in 2006 to treat people with advanced kidney cancers.

“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,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Sutent is a type of targeted therapy called a kinase inhibitor that works by blocking several enzymes that help cancer cells grow. The FDA based its approval on a trial of 615 people who’d had their kidney cancer removed and were at high risk of the cancer coming back. The study measured the amount of time it took for the cancer to come back, or for another cancer to occur, or for the patient to die from any cause. After 5 years, 59.3% of the people who received Sutent were still alive with no evidence of cancer, compared to 51.3% of the people who received a placebo (fake pill).

Common side effects of Sutent include fatigue, diarrhea, mouth sores, nausea and vomiting, decreased appetite, abdominal pain, skin reactions on the hands and feet, high blood pressure, bleeding, taste changes, indigestion and low levels of blood platelets.

Severe side effects are possible. They may include severe liver damage, heart failure, heart attack, abnormal heart rhythm, high blood pressure, bleeding, metabolic abnormalities, blood clots, high levels of protein in the urine, thyroid dysfunction, low blood sugar, breakdown of the bone of the jaw, wound healing complications, and serious skin reactions.

Women who are pregnant should not take Sutent because it may cause harm to a developing fetus.

The labeling for Sutent contains a boxed warning about the risk of severe liver damage, which may cause liver failure or death.

Sutent is marketed by Pfizer, Inc.

The American Cancer Society medical and editorial content team

Our team is made up of doctors and oncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing.


American Cancer Society news stories are copyrighted material and are not intended to be used as press releases. For reprint requests, please see our Content Usage Policy.