FDA approves new labeling for advanced RCC treatment

February 15, 2007

The FDA has approved new labeling for sunitinib malate (Sutent) to include first-line treatment of advanced renal cell carcinoma. The labeling change is based on results of a large phase III trial that showed prolonged progression-free survival.

The FDA has approved new labeling for sunitinib malate (Sutent) to include first-line treatment of advanced renal cell carcinoma. The labeling change is based on results of a large phase III trial that showed prolonged progression-free survival.

In the study, 750 treatment-naive patients with metastatic RCC received either sunitinib or the comparator, interferon-alfa. Patients taking sunitinib achieved a median progression-free survival of 11 months and also experienced a five-fold higher objective response rate compared with those receiving interferon as first-line RCC treatment (27.5% vs. 5.3%), according to researchers, whose findings were published recently in the New England Journal of Medicine (2007; 356:115-24).

"For many years, the options available for people with metastatic kidney cancer have been very limited," said lead investigator Robert Motzer, MD. "To have such a high percent of patients respond to this treatment is remarkable and a sign of the significant benefit Sutent may bring to patients fighting this deadly cancer."

Side effects for sunitinib in this trial were generally mild or moderate. The most common treatment-related adverse events of any grade were fatigue, diarrhea, nausea, altered taste, mucositis/stomatitis, hypertension, anorexia, and bleeding.

Look for more news on sunitinib and sorafenib (Nexavar) in the March issue of Urology Times.