FDA advisory panel split on Sutent as adjuvant kidney cancer therapy

The US FDA’s advisory panel, the Oncologic Drug Advisory Committee, has voted 6 in favor and 6 against the benefit-risk profile for Pfizer’s Sutent (sunitinib) as a post-surgical therapy for renal cell carcinoma (RCC).

A verdict is due on the company’s bid to extend the label in this indication by January 2018. The panel provides non-binding guidance to the FDA.

The application is supported by data from the Phase III S-TRAC trial, which met its primary endpoint of improving disease-free survival.

The drug has been approved in the USA since 2006, where it is the most commonly prescribed first-line treatment for advanced RCC.