Aveo endures yet another FDA setback

An optimistic Aveo Oncology recently plotted a path back to Phase III with its thrice-failed cancer drug, but the FDA wants to see more data before signing off on that idea, dealing another blow to the troubled biotech. In March, looking over data from a failed Phase II study testing its tivozanib on colorectal cancer, Aveo noted that patients with low levels of the protein NRP-1 showed an improvement in progression-free survival on the drug compared to placebo, suggesting a path forward. The FDA was less convinced, however, telling the company that "insufficient data exists to determine the appropriateness of this subgroup" for a Phase III study, according to Aveo. Now the Cambridge, MA, biotech is planning to work on its NRP-1 diagnostic in hopes of better establishing the link. More

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