Pfizer’s Sutent® (sunitinib malate) USFDA-Approved to Include New First-Line Advanced Kidney Cancer Data in Product Label
The USFDA has approved inclusion of first-line treatment of advanced renal cell carcinoma (RCC) in the label of Pfizer (NYSE: PFE)’s Sutent® (sunitinib malate), following large Phase 3 clinical data that demonstrated prolonged progression-free survival.
Advanced renal cell carcinoma (RCC) is a type of advanced kidney cancer that is relatively rare but serious disease and historically has been among the most therapy-resistant tumors.
Sutent® was originally approved in January 2006 for the treatment of advanced kidney cancer under the accelerated approval provision, based on partial response rates and duration of response. With the new labeling, the accelerated approval has been converted to regular approval.
Results of the said Phase 3 study have been published in the January 11, 2007 issue of The New England Journal of Medicine.
Find more details from the full report.
[Photo Credit: Best Syndication]
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