FDA Panel Mixed on Pfizer Expanded Use for Sutent

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.