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.

This content is written, edited and published by EP Vantage and is distributed by Evaluate Ltd. All queries regarding the content should be directed to: news@epvantage.com

EP Vantage is a unique, forward-looking, news analysis service tailored to the needs of pharma and finance professionals. EP Vantage focuses on the events that will define the future of companies, products and therapy areas, with detailed financial analysis of events in real-time, including regulatory decisions, product approvals, licensing deals, patent decisions, M&A.

Drawing on Evaluate, an industry-leading database of actual and forecast product sales and financials, EP Vantage gives readers the insight to make value-enhancing decisions.

EP Vantage SM ©2018 EP Vantage Ltd