Pfizer’s Sutent split ODAC vote reflects expert hesitance on potential in adjuvant RCC setting; approval finds backing
Pfizer’s (NYSE:PFE) Sutent (sunitinib) will find low uptake in adjuvant renal cell carcinoma (RCC) setting, but approval could still come through despite a split Oncologic Drug Advisory Committee (ODAC) vote, experts said.
On 19 September, the FDA’s ODAC voted 6-6 for the use of Sutent as an adjuvant RCC treatment following a nephrectomy.
Before release of data from the pivotal study, S-TRAC, this news service reported that experts had concerns about adjuvant Sutent use because of the drug’s known toxicities. Since then, the PROTECT Phase III adjuvant study with a another TKI -- Novartis’ (VTX:NOVN) Votrient (pazopanib) -- failed to prove efficacy. This along with past adjuvant setting failures and statistically but clinically less significant S-TRAC results further fueled expert ambivalence about Sutent’s adjuvant use.
Nonetheless, experts said they would prefer to have the choice to use Sutent as an adjuvant for certain patients even though it will likely not be a popular choice across the RCC population. The fact that the trial met its disease-free survival (DFS) primary endpoint made them suggest that approval is still a possibility.