FDA Panel Splits on Adjuvant Sunitinib in High-Risk RCC

September 19, 2017 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are at high risk of recurrence. The panel was voting on the risk-benefit profile of sunitinib in this setting based on findings from the phase III S-TRAC trial, which were presented at the 2016 ESMO Congress and published in the New … (leggi tutto)