FDA Oncologic Drug Advisory Committee voted 6 in favor and 6 against the benefit-risk profile for Sutent (sunitinib) in patients at high risk of recurrent renal cell carcinoma after surgery.- Pfizer.

Pfizer Inc. has announced that the FDA Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for Sutent (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney). The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application (sNDA) currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018.

Approximately 75 percent of patients with clear cell RCC are non-metastatic, and 70-80 percent will have a nephrectomy with curative intent, or surgical removal of the tumor. High-risk patients represent approximately 15 percent of all patients with primary resected RCC and approximately 60 percent of these high-risk patients will have recurrence and develop metastatic disease within five years. The current treatment is surgery followed by observation. This treatment is suboptimal for patients at high risk of recurrence.

The sNDA under review by the FDA is based on results from the S-TRAC trial, a randomized double-blind Phase III 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 (DFS), and the results were published by The New England Journal of Medicine in October 2016.