Sutent Gets Regular FDA Approval for RCC

ROCKVILLE, Maryland—FDA officials have granted regular approval to Sutent (sunitinib malate, Pfizer) for the treatment of advanced renal cell carcinoma (RCC) patients who failed prior cytokine-based therapy, upgrading it from the accelerated approval granted in January 2006. The new labeling also includes the first-line use of Sutent for treating advanced RCC.

The agency gave the drug, an oral multikinase inhibitor, initial marketing approval for two indications simultaneously last year—advanced RCC and gastrointestinal stromal tumors. Sutent received its RCC approval on the basis of partial-response and response-duration rates obtained in two single-arm, multicenter clinical studies. FDA based its decision to upgrade Sutent's approval status on an interim analysis of a large phase III trial showing clinical benefit in patients treated with the drug (N Engl J Med 356:115-124, 2007).

The trial randomized 750 treatment-naive metastatic RCC patients to Sutent or interferon-alfa. Sutent-treated patients had significantly longer median progression-free survival: 11 months vs 5 months for interferon (HR 0.42). The Sutent group had a 27.5% response rate vs 5.3% for IFN. Overall survival data have not reached maturity.