New labeling of Sutent (sunitinib malate, Pfizer) has been approved that includes first-line treatment of advanced renal cell carcinoma (RCC).

The approval is based on efficacy data from a large Phase III trial showing prolonged progression-free survival. In the large, randomized trial, 750 treatment-näive patients with metastatic RCC received either Sutent or the comparator interferon-alfa, the current standard of care.

Key findings showed that Sutent patients experienced a fivefold higher objective response rate, achieved nearly double the median progression-free survival observed with interferon-alfa, and was generally well tolerated with fewer discontinuations (N Engl J Med. 2007;356:115-124).

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“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,” said Robert Motzer, MD, lead investigator of the Phase III trial and attending physician at Memorial Sloan-Kettering Cancer Center in New York City.