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What is a special protocol assessment worth, anyway?

Date May 14, 2013

After bending over backwards to counter criticism and approve more drugs, the FDA might have drawn a line in the sand. The scathing panel opinions on Aveo Oncology and Delcath Systems’ respective cancer projects two weeks ago were unambiguous and, despite each having apparently met the terms of its special protocol assessment, chances of approval of either are now hopelessly low.

At least three other companies are similarly pinning their hopes on success in single oncology studies that, under an SPA, use improvement in progression-free survival as their primary endpoint (see table below). Aveo and Delcath’s crushing setbacks could be making it difficult for these groups’ management teams to sleep easy.

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