FDA approves kinase inhibitor for adjuvant RCC treatment

The US Food and Drug Administration (FDA) recently approved Sutent (sunitinib malate; Pfizer, Inc) for the adjuvant treatment of adults at high risk of kidney cancer (renal cell carcinoma) recurrence following nephrectomy.  

“This is the first adjuvant treatment approved for patients with renal cell carcinoma (RCC), 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. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”

Sunitinib is a kinase inhibitor that works by blocking enzymes that promote cell growth. First approved in 2006 for the treatment of some patients with gastrointestinal stromal tumors and advanced renal cell carcinoma, it is also approved for patients with a certain type of pancreatic cancer.

The approval of sunitinib for the adjuvant treatment of renal cell carcinoma was based on a randomized trial of 615 patients with a high risk of recurrent renal cell carcinoma following nephrectomy.

The study measured the time of recurrence of the same tumor, development of an unrelated cancer, or death from any cause (disease-free survival). After 5 years, 59.3% of patients treated with sunitinib had not experienced cancer recurrence or death, compared with 51.3% of patients receiving placebo.

Common side effects include fatigue, 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 of the jaw, and wound healing complications.

The labeling for sunitinib contains a boxed warning to alert health-care professionals and patients about the risk of severe hepatoxicity, which may result in liver failure or death.