The US Food and Drug Administration (FDA) has approved Sutent (sunitinib malate) for the adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy.
Kidneys
“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,” explained Dr Richard Pazdur, 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.”
Pfizer’s Sutent is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumours and advanced renal cell carcinoma. It is also approved for patients with a certain type of pancreatic cancer.
This approval — for the adjuvant treatment — was based on a randomised trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. In the trial, the amount of time from the start of the trial to when the cancer returned, an unrelated cancer developed or for death to occur from any cause was measured. It was found that 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.
