3/31/2009
NBTS advocated for patients' rights to a range of treatment options at ODAC hearing
Please see the article FDA grants accelerated approval for Avastin in previously-treated GBM for an update to the information below.
The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) held an open public hearing to inform its consideration of bevacizumab, or Avastin®. Avastin is approved for use in patients with other cancers and is now in clinical trials for patients with previously-treated glioblastoma. Its manufacturer, Genentech, seeks accelerated approval for this use.
National Brain Tumor Society advocates for patients' rights to a range of treatment choices and options, and NBTS represented the brain tumor patient community and relevant issues to ODAC at the March 31 hearing.
Based upon the body of data available, ODAC voted unanimously that the response seen with Avastin in patients with previously-treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. ODAC's vote is still a recommendation and not a formal approval; the FDA is expected to make its decision on whether to grant accelerated approval of Avastin by May 5, 2009.
