Posts tagged ‘sunitinib’

SUTENT (sunitinib) Advisory Committee Meeting

On Tuesday, April 12, 2011 the FDA Oncology Advisory Committee will discuss Pfizer‘s application for the use of SUTENT in patients with unresectable pancreatic neuroendocrine tumors.  SUTENT has 2 approved indications, including use in patients with advanced renal cell carcinoma.

Based on the issues raised in the FDA Briefing Document, Pfizer might want to spend some time explaining their regulatory/development strategy.  Specifically, the FDA seems to have challenged the company’s choice of a single Phase 3 study using Progression Free Survival as the end point instead of Overall Survival, especially since Pfizer chose not to avail themselves of an End of Phase 2 meeting with the FDA.  It doesn’t appear that Pfizer got FDA agreement through an SPA either.

The Advisory Committee will probably focus on the conduct of the study though and the role the DMC had in the decision making process other than safety.  The major issue seems to be the halting of the trail with only 28% of the subjects enrolled and the predictive value of this limited number of PFS patients from a single study.

One study with limited enrollment, PFS instead of OS – I think the discussion will be short and predictable.  The recommendation will be negative.