The ASCO Post, a newspaper intended for everyone with an interest in oncology, 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 Oncology and Experimental Therapeutics at City of Hope Comprehensive Cancer Center in Duarte, CA.
Gabriel Hortobagyi, MD, who attended the ODAC meeting as a consultant to Genentech, said “There is an urgent need for the FDA and the cancer community to agree upon exactly what qualifies a drug for approval.” Dr. Hortobagyi is Professor of Medicine and Chairman, Department of Breast Medical Oncology, at The University of Texas M.D. Anderson Cancer Center in Houston, TX. “There would certainly be differences of opinion from the various corners as to the requisite degree of benefit,” he added, but “by having this conversation we should arrive at what is commensurate with the expectations for advanced breast cancer.”
“If we only accepted cancer treatments that improve survival, we would severely limit options for our patients,” said Edith P. Perez, MD, Director of the Breast Cancer Program and Professor of Medicine at Mayo Clinic in Jacksonville, FL.
A decision by FDA on bevacizumab’s breast cancer indication is expected later this year.
