FDA on Thursday approved sunitinib malate (Sutent—Pfizer) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after a kidney has been removed. Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back. "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 FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. Sunitinib malate is a kinase inhibitor that works by blocking several enzymes that promote cell growth. The drug was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for patients with a certain type of pancreatic cancer. The approval of Sutent for the adjuvant treatment of renal cell carcinoma was based on a randomized trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. Severe adverse events of the drug include severe liver damage, heart failure, heart attack, hypertension, and bleeding.