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FDA approves Sutent to reduce risk for recurrent kidney cancer
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The FDA today approved sunitinib malate for the adjuvant treatment of adults at high risk for recurrent renal cell carcinoma following nephrectomy.
“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 for the cancer returning,” 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, said in a press release. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”
Sunitinib malate (Sutent, Pfizer) — a kinase inhibitor that blocks several enzymes that promote cell growth — first received approval in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It also is approved for certain types of pancreatic cancer.
The agency based this decision, in part, on data from a randomized trial of 615 patients at high risk for recurrent renal cell carcinoma following nephrectomy. Researchers evaluated DFS among patients assigned sunitinib malate vs. placebo.
Overall, 59.3% of patients assigned sunitinib malate achieved 5-year DFS compared with 51.3% of patients assigned placebo.
Adverse events associated with sunitinib included fatigue, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia and thrombocytopenia.
Severe adverse events included hepatotoxicity; low left ventricular ejection fraction; myocardial ischemia/infarction; prolonged QT intervals/Torsade de Pointes; hypertension; hemorrhagic events; tumor lysis syndrome; thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome; proteinuria; thyroid dysfunction; hypoglycemia; osteonecrosis and wound healing complications.
The drug’s label contains a boxed warning regarding the risk for severe hepatotoxicity, which can cause liver failure or death.
The FDA’s decision follows a split vote from the Oncologic Drug Advisory Committee on whether the risk-benefit profile of sunitinib malate is acceptable for this indication.