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# FDA Panel Mixed on Pfizer Expanded Use for Sutent
- URL: https://www.fdaweb.com/fda-panel-mixed-on-pfizer-expanded-use-for-sutent/
- Published: 2017-09-19T12:00:00.000Z
- Updated: 2026-09-14T22:51:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139667

FDA’s Oncologic Drug Advisory Committee has voted six in favor and six against the benefit-risk profile for Pfizer’s Sutent (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after surgical removal of the cancer-containing kidney. FDA has set a user fee review action date in 01/2018.

The supplemental NDA is based on data from the S-TRAC trial, a randomized double-blind Phase 3 trial of adjuvant Sutent vs. placebo in 615 patients with locoregional, resected RCC at high risk of recurrence. The study met its primary endpoint of improving disease-free survival, and results were published by *The New England Journal of Medicine* in 10/2016.

Sutent was first approved by FDA in 2006 for treating advanced RCC, where it is the most widely prescribed first-line treatment, according to Pfizer.