Posted by Michael Wonder on 16 Nov 2017
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
16 November 2017 - FDA approves adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy.
The U.S. FDA today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back.
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% of patients treated with Sutent had not experienced cancer recurrence or death compared with 51.3% of patients receiving placebo.
