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FDA Expands Approval of Sunitinib Malate in Renal Cell Carcinoma After Nephrectomy

Posted: Friday, November 17, 2017

On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adults who are at high risk of renal cell carcinoma after nephrectomy. First approved in 2006, sunitinib is indicated for the treatment of advanced renal cell carcinoma; gastrointestinal stromal tumor after disease progression on or intolerance to imatinib; and progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

The recent expanded approval was based on the randomized phase III S-TRAC trial of 615 patients at high risk of recurrent renal cell carcinoma following nephrectomy. 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. The labeling for sunitinib contains a boxed warning about the risk of hepatoxicity, which may result in liver failure or death.