FDA approves Sutent to treat high risk patients post surgery with renal cell carcinoma

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.

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. The study measured the amount of time after the start of the trial that it took for the cancer to come back, for the patient to develop another unrelated cancer, or for death to occur from any cause (disease-free survival). After five years, 59.3 percent of patients treated with Sutent had not experienced cancer recurrence or death compared with 51.3 percent of patients receiving placebo. The labeling for Sutent contains a boxed warning to alert healthcare professionals and patients about the risk of severe liver damage (hepatoxicity), which may result in liver failure or death.