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Sutent Approved to Reduce Risk of Kidney Cancer Recurrence

New indication marks first adjuvant treatment after nephrectomy

Sunitinib malate (Sutent, Pfizer Inc.) has received FDA approval for the adjuvant treatment of adults who face a high risk of renal cell carcinoma returning after a 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,” 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.

The National Cancer Institute estimates approximately 63,990 patients will be diagnosed with kidney and renal cell pelvis cancer this year, and 14,440 will die of the disease.

Sunitinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It was first approved in 2006 for the treatment of certain 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 high risk of recurrent renal cell carcinoma following nephrectomy. The study measured the amount of time after the start of the trial that it took for the cancer to come back, for the patient to develop another unrelated cancer, or for death to occur from any cause (disease-free survival). After five 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 of sunitinib 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 of sunitinib include hepatotoxicity, heart failure (low left ventricular ejection fraction), myocardial ischemia or infarction, abnormal heart rhythm (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.

Patients should stop taking sunitinib if serious skin reactions occur (necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis). Women who are pregnant should not take sunitinib because it may cause harm to a developing fetus.

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

Source: FDA; November 17, 2017.

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