Approval of Stutent Expanded to Reduce Carcinoma Recurrence

Mathew Shanley

Stutent (sunitinib malate), which was developed by Pfizer and originally approved by the U.S. Food and Drug Administration (FDA) in 2006 for advanced renal cell carcinoma and gastrointestinal (GI) stromal tumors, received an approval expansion today.

The FDA gave Pfizer the go-ahead to indicate the therapy for the treatment of adult patients who are at high risk of renal cell carcinoma, a cancer characterized by cancerous cells developing inside the small tubes of the kidney.

“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, M.D., 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 the official press release. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”

Per the American Cancer Society, approximately 64,000 new cases of renal cell carcinoma are diagnosed annually. The expanded approval of this adjuvant treatment is intended to reduce the risk of the cancer recurring after an initial surgical removal of the tumor.

Sunent, which is also approved for patients with a specific type of pancreatic cancer, operates as a kinase inhibitor that operates by blocking enzymes that promote cell growth. Today’s announcement is based on a randomized trial including 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy, and it was concluded that after 5 years of follow-up, 59.3% of patients treated with Sutent had not experienced cancer recurrence or death; an 8% improvement compared to patients treated with placebo.

Common side effects of Stuent include fatigue, diarrhea, inflammation of the mucous membranes and inside the mouth, nausea, decreased appetite/anorexia, vomiting, abdominal pain, skin reactions, high blood pressure, hypertension, altered taste, indigestion, and thrombocytopenia. More severe side effects include severe liver damage, and Stutent comes with a boxed warning that notes the risk for liver failure.

In 2015, new data was published in Lancet Oncology  that showed sunitinib’s clinical benefit in patients with thymic carcinoma.

For more breaking news from the FDA, follow Rare Disease Report on Facebook and Twitter.
Printer Printing...