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Bevacizumab is a monoclonal antibody that targets the circulating growth factor Vascular Endothelial Growth Factor (VEGF) which promotes new blood vessel growth to feed growing tumours. By blocking VEGF action, tumours can be deprived of their blood supply and die. Since 2008, the drug bevacizumab (Avastin) has been approved by the Food & Drug Administration (FDA) under its “accelerated approval” mechanism for use in combination with paclitaxel (Taxol), to treat HER2-negative metastatic breast cancer patients who have not yet received chemotherapy for advanced disease. This approval was based upon the results of ECOG E2100 (N Engl J Med 2007; 357:2666-2676) and a dossier based upon these results submitted to the FDA by (then) Genentech BioOncology. ECOG E2100 was an open label study testing weekly paclitaxel +/- bevacizumab in first line metastatic breast cancer, which yielded both the longest progression free survival (PFS) (12 months) and absolute difference (5.5 months) seen to date in randomized trials in this setting. As part of the FDA submission, an independent radiologic review verified the PFS and response endpoints found in E2100. No significant survival advantage was found. Since the report of E2100, studies employing the exact regimen have shown similar results. On Tuesday, July 20th, 2010, the FDA received a recommendation from its Oncologic Drugs Advisory Committee (ODAC) to withdraw this approval, after the review of two placebo-controlled randomized studies, AVADO and RIBBON1, comparing different chemotherapy regimens +/- bevacizumab in first line metastatic breast cancer. Both studies met their predefined endpoints for PFS but the magnitude of the difference was less than reported with the E2100 paclitaxel/bevacizumab regimen. Neither study showed a survival advantage for the bevacizumab-containing regimens. The toxicity profile observed in these studies was similar to previous reports. Avastin is not reimbursed on the PBS in Australia for breast cancer treatment and we use it only under very rare circumstances. | Tamoxifen | Chemotherapy for Breast Cancer | After Treatment - What Now? | Causes of Breast Cancer | Breast Cancer Myths | Family History | Herceptin | Femara, Arimidex, Aromasin | Adjuvant Chemotherapy | Zoladex and Stopping the ovaries | Stage, Grade, Receptors | Zometa, XGeva | Alopecia from Hormonal Therapy | New treatments | Lapatinib 'Tykerb' | Avastin | Pertuzumab | | What's New | FAQ Page | Living with chemotherapy | Dietary Advice | Exercise | The Flu Vaccine | Insomnia | Marijuana | Alternative Medicine | Managing Menopause | Advice to Carers | Breast Cancer | Pain | Useful Tips | Chemotherapy: The What and How | MRI Screening | | Your Cancer Information | | Return Home | New Patients | Services and Clinics | Useful Links | Contact Us | Download Page | Cancer Information | |
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