The Food and Drug Administration has approved sunitinib malate for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) 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 of 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 written statement.

Sunitinib malate is an oral multitargeted tyrosine kinase inhibitor that has been approved for the treatment of advanced RCC since 2006.

Approval for adjuvant treatment of RCC was based on median disease-free survival of 6.8 years for patients receiving sunitinib malate, compared with 5.6 years for patients receiving placebo in S-TRAC, a phase III trial of 615 patients with high risk of recurrent RCC following nephrectomy. In the trial, presented at the European Society for Medical Oncology Congress in 2016 and published in the New England Journal of Medicine, patients were randomized 1:1 to receive either 50 mg sunitinib malate once daily, 4 weeks on treatment followed by 2 weeks off, or placebo. Overall survival data were not mature at the time of data analysis.

The most common adverse reactions to sunitinib in the trial were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.

Severe side effects 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. A boxed warning alerts health care professionals and patients about the risk of hepatoxicity, which may result in liver failure or death.

Sunitinib malate is marketed as Sutent by Pfizer. The recommended dose for the adjuvant treatment of RCC is 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off for nine 6-week cycles.

Full prescribing information is available here.


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