Avastin, ODAC, and the FDA: Are We Drafting the Right Players?

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Although the calendar said “summer” and baseball season was in high gear, July seemed to be an early fall for Avastin in breast cancer. The Oncology Drugs Advisory Committee (ODAC) of the FDA voted 12 to 1 that the AVADO and RIBBON1 trials did not provide confirmatory evidence supporting the original ECOG 2100 study that had led to accelerated approval of bevacizumab in combination with paclitaxel for advanced breast cancer. The FDA will decide in September whether to withdraw the label for the agent. A previous ODAC vote, in 2007, was 5 to 4 against approval, a recommendation not honored in the subsequent FDA decision. To date, there have been no fewer than 5 randomized clinical trials of chemotherapy with or without bevacizumab. Of these, the first (capecitabine ± bevacizumab) showed no difference in progression-free survival (PFS). The second (ECOG 2100; paclitaxel ± bevacizumab) showed major improvement in PFS. The next 3 trials—all placebo-controlled—showed changes in PFS that were, though all statistically significant, arguably not clinically compelling, with improvements in PFS of 2 to 3 months. None of these studies, nor a meta-analysis, suggests a survival advantage for adding bevacizumab in advanced breast cancer. These results leave more questions than answers. The second most common, after the question of bevacizumab itself, is, “what should be the end points for oncology drug approval?” The FDA has offered guidance for clinical trial end points and approval of cancer drugs (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf). A variety of end points can lead to approval, including...

Harold J. Burstein, MD, PhD, editor-in-chief of JNCCN, is an Associate Professor of Medicine at Harvard Medical School and a medical oncologist at Dana-Farber Cancer Institute and Brigham & Women's Hospital. He is a clinician and clinical investigator specializing in breast cancer.Dr. Burstein attended Harvard College and earned his MD at Harvard Medical School, where he also earned a PhD in immunology. He trained in internal medicine at Massachusetts General Hospital and was a fellow in medical oncology at Dana-Farber before joining the staff.Dr. Burstein's clinical research interests include novel treatments for early- and advanced-stage breast cancer and studies of quality of life and health behavior among women with breast cancer. He has written widely on breast cancer in both traditional medical journals and on the web, including New England Journal of Medicine and Journal of Clinical Oncology. International committees focusing on cancer treatments that he has or continues to participate in include the NCCN Clinical Practice Guidelines Breast Cancer Panel, St. Gallen Breast Cancer Panel, CALGB Breast Cancer Committee, ASCO Health Services Research and Clinical Research Committees, the National Quality Forum Breast Cancer Technical Panel, and other ASCO expert panels.
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