BioCentury
ARTICLE | Regulation

Avastin's quality of life

April 6, 2009 7:00 AM UTC

Even though an FDA panel voted unanimously last week that the objective response rates in Phase II trials of Avastin bevacizumab to treat glioblastoma multiforme are reasonably likely to predict clinical benefit for the purpose of accelerated approval, they did not endorse the use of ORR as a primary endpoint in the indication.

Instead, members of FDA's Oncologic Drugs Advisory Committee said Avastin is a unique case because of its mechanism, and because the totality of data - including improvements in quality of life - support its use in GBM...