FDA Expands Approval of Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma After Nephrectomy


Today, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adult patients who are at a high risk of recurrent renal cell carcinoma after nephrectomy.

“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. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”

S-TRAC Trial Details

The approval of sunitinib for the adjuvant treatment of renal cell carcinoma was based on the randomized phase III S-TRAC trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. The study measured disease-free survival.

After 5 years, 59.3% of patients treated with sunitinib had not experienced cancer recurrence or death, compared with 51.3% of patients receiving placebo.

Common side effects of sunitinib include fatigue, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.

Severe side effects of sunitinib include hepatotoxicity; low left-ventricular ejection fraction; myocardial ischemia/infarction; prolonged QT intervals/Torsade de Pointes; hypertension; hemorrhagic events; tumorlysis syndrome; thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome; proteinuria; thyroid dysfunction; hypoglycemia; osteonecrosis; and wound healing complications.

Patients should stop taking sunitinib if serious skin reactions occur (necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis). Women who are pregnant should not take sunitinib because it may cause harm to a developing fetus.

The labeling for sunitinib contains a boxed warning to alert health-care professionals and patients about the risk of hepatoxicity, which may result in liver failure or death.

The FDA granted the approval of Sutent to Pfizer Inc.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.