CAMBRIDGE, Mass. ( TheStreet) -- Next week is crucial for Aveo Oncology. (AVEO - Get Report) On Tuesday, the FDA will post to its web site the agency's clinical review of Aveo's experimental kidney cancer drug tivozanib. Two days later, on Thursday, FDA will convene an independent advisory panel which will dissect the tivozanib data and vote on whether or not to recommend the drug's approval.
I believe the FDA briefing documents will raise significant concerns about tivozanib's efficacy in kidney cancer and the conduct of the pivotal phase III study. This will lead the panel to vote negative, meaning a recommendation against the drug's approval.
Admittedly, my conviction level for this prediction isn't all that strong. Today's FDA seems addicted to approving all drugs, so the agency may be unwilling to subject tivozanib to the scrutiny it deserves. If the FDA takes it easy on tivozanib, the advisory panel may do the same. Tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) over Onyx Pharmaceuticals' (ONXX) Nexavar. This was the primary endpoint of the phase III study, so on this basis, the drug could get a positive vote.
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