FDA Accepts Pfizer sNDA for Sutent Expanded Use

FDA has accepted a Pfizer supplemental NDA for Sutent (sunitinib) seeking to expand its use to include adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). The user fee review target date is 1/2018.

The submission is based on results from the S-TRAC trial, a randomized double-blind Phase 3 study 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 (DFS), and the results were published online by the New England Journal of Medicine 10/2016. Data showed that after up to one year of treatment, the median DFS in participants treated with Sutent after surgery was 6.8 years compared with 5.6 years for patients treated with placebo as assessed by blinded independent central review, according to the company.