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Regulators at the FDA have weighed the data for Aveo's tivozanib , raising a simple question that could prove vexing for the biotech: Should another clinical trial be required before the agency delivers its verdict on the cancer drug, given that alternative treatments are available? Aveo ($AVEO) will make its case for immediate approval to an outside panel of FDA experts on Thursday, but the slim review document released this morning clearly spooked hopeful investors, pushing down the biotech's stock more than 25%.
Why the jitters? Tivozanib hit its primary endpoint, demonstrating a slim but statistically significant improvement in progression-free-survival of patients with advanced renal cell carcinoma when compared to Nexavar (sorafenib). But the sorafenib arm experienced a slightly better overall survival rate, and Aveo has been trying to explain it away ever since.
The developer had to start in the spring of 2012 at a pre-NDA meeting. According to the review document, "the FDA expressed concern about the adverse trend in overall survival in the single...