FDA Expands Approval of Adjuvant Therapy for Adults at High Risk of Recurring Kidney Cancer


The US Food and Drug Administration (FDA) has approved an adjuvant treatment for adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.

Sunitinib malate (Sutent, Pfizer, Inc) is a kinase inhibitor that was initially approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma as well as patients with a certain type of pancreatic cancer.

The approval of sunitinib malate for the adjuvant treatment of renal cell carcinoma came following results of a randomized trial involving 615 patients. After a 5-year follow-up period from nephrectomy, 59.3% of patients treated with sunitinib malate had not experienced cancer recurrence or death, compared with 51.3% of patients receiving placebo.


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Common adverse effects of sunitinib malate include fatigue, diarrhea, mucositis, stomatitis, nausea, decreased appetite or anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension , bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.

“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,” said Richard Pazdur, MD, 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, in a press release (November 16, 2017). “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”—Zachary Bessette