COLD SPRING HARBOR, N.Y., Sept. 1 /PRNewswire/ — The ASCO
Post captured initial reactions to the Oncologic Drugs Advisory
Committee (ODAC) recommendation that the breast cancer indication
for bevacizumab (Avastin) be revoked in interviews with ODAC voting
members, breast cancer specialists, oncologists in private
practice, third-party payers, and a patient advocate. These
reactions are available online now at ASCOPost.com and appear in
the September issue of the publication.
“It is important that the breast cancer community rest assured
that ODAC is an independent, unbiased panel of experts in oncology
whose mission is to provide their best objective scientific and
clinical recommendations to the FDA for drug approval,” said ODAC
Chair, Wyndham Wilson, MD, PhD. Dr. Wilson is Chief of the Lymphoid
Therapeutics Section of the Center for Cancer Research, National
Cancer Institute.
Bevacizumab is currently approved in combination with paclitaxel
for the first-line treatment of advanced HER2-negative breast
cancer, based on encouraging results of the E2100 trial (N
Engl J Med 357:2666-2676, 2007). The FDA provisionally
granted accelerated approval but requested confirmatory data from
the manufacturer, Genentech. In November 2009, Genentech supplied
the results of the AVADO (J Clin Oncol 28:3239-3247, 2010)
and RIBBON-1 trials (J Clin Oncol 27(abstract 1005), 2009).
On July 20, 2010, ODAC recommended against conversion to full
approval.
Joanne Mortimer, MD, a member of ODAC, who voted to approve
bevacizumab in advanced breast cancer in December 2007 based on the
E2100 study, said, “The additional data from AVADO and RIBBON-1
supported an increased response rate, but also confirmed the
increased toxicity and lack of survival advantage with bevacizumab.
Like the majority of panel [ODAC] members, I could not recommend
approval.” Dr. Mortimer is Director of the Women’s Cancers’ Program
and Professor of Medical Oncolo
‘/>”/>
