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ODAC split on Sutent for adjuvant RCC

September 19, 2017 9:28 PM UTC

FDA’s Oncologic Drugs Advisory Committee voted 6-6 on Tuesday that the benefit-risk profile of Sutent sunitinib from Pfizer Inc. (NYSE:PFE) is acceptable for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy. The drug, which is already approved in the U.S. to treat advanced RCC, has a January PDUFA date for the indication.

In briefing documents released ahead of the meeting, FDA asked the panel to discuss whether Sutent showed an improvement on the primary endpoint of disease-free survival (DFS) in the Phase III S-TRAC trial and whether DFS as defined in S-TRAC is a clinically relevant endpoint. The briefing documents noted that there is no widely agreed upon definition of DFS in RCC as there is in breast cancer...