FDA Expands Approval of Kidney Cancer Treatment to Recurrence Prevention

NOVEMBER 17, 2017
Officials with the FDA have expanded the approval of sunitinib malate (Sutent, Pfizer) for adjuvant treatment in adult patients who are at high risk of kidney cancer returning after kidney removal.

Sunitinib malate was initially approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma, as well as certain types of pancreatic cancer. With the new indication, the treatment can be taken after the initial surgical removal to lower the risk of cancer recurrence.

The expanded approval is based on a clinical trial including 615 patients with a high risk of recurrent kidney cancer following nephrectomy. The researchers measured the amount of time after the start of the trial that it took for the cancer to recur, for the patient to develop another unrelated cancer, or for death to occur from any cause. After 5 years, 59.3% of the patients treated with sunitinib malate had not experienced cancer recurrence or death compared with 51.3% of patients who received a placebo.

Common adverse effects include fatigue, diarrhea, inflammation of mucous membranes and inside the mouth, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and low levels of blood platelets.

Sunitinib malate carries a boxed warning to alert health care professionals and patients about a potential risk of liver damage.


FDA expands approval of Sutent to reduce the risk of kidney cancer returning [news release]. FDA’s website. . Accessed November 17, 2017.