FDA advisory committee split on benefit-risk profile for Pfizer's SUTENT
Pfizer announced that the U.S. Food and Drug Administration's Oncologic Drug Advisory Committee voted six in favor and six against the benefit-risk profile for SUTENT as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after nephrectomy. The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018. The sNDA under review by the FDA is based on results 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 the results were published by The New England Journal of Medicine in October 2016. The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision making process.