Pfizer Announces Outcome of FDA Advisory Committee Meeting for SUTENT® in Patients at High Risk of Recurrent Renal Cell Carcinoma after Surgery

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration’s (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.

http://press.pfizer.com/press-release/pfizer-announces-outcome-fda-advisory-committee-meeting-sutent-patients-high-risk-recu