The Oncology Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) has voted 12 to one that Avastin® (bevacizumab) in combination with paclitaxel should no longer be approved for initial therapy for metastatic HER2-negative breast cancer.
Metastatic breast cancer refers to cancer that has spread to distant sites in the body. Chemotherapy is a cornerstone of therapy for metastatic breast cancer; however, novel therapeutic approaches are now providing more targeted methods of treatment.
Avastin is an agent targeted against the vascular endothelial growth factor (VEGF). VEGF is involved in the growth and spread of cancer cells, which Avastin reduces or prevents. Avastin is approved for the treatment of some colon, kidney, brain, and lung cancers as well as breast cancer.
The ODAC is a committee that makes recommendations to the FDA regarding approval of drugs for use in oncology. Although the FDA is not required to follow recommendations of the ODAC, it often does.
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The committee’s current recommendation that Avastin combined with chemotherapy not be used as initial therapy in advanced breast cancer is based on their review of three studies involving more than 2,400 patients. Their decision is based on evaluating the risks and benefits of treatment with the combination of Avastin and chemotherapy compared with chemotherapy alone. The initial study that led to the accelerated approval from the FDA in 2008 resulted in a progression-free survival improvement of 5.5 months with the addition of Avastin to paclitaxel compared with paclitaxel alone. Two subsequent studies showed smaller improvements in progression-free survival. There is still no evidence, however, that Avastin improves overall survival among women with breast cancer.
Avastin is still currently available for advanced breast cancer patients; the FDA is expected to make a decision on whether or not this should remain an option for initial treatment of this disease by September 17, 2010. The decision will not affect use of Avastin for other cancers.
Reference: Genentech press release. Genentech Provides Update From Avastin FDA Advisory Committee Meeting. Accessed July 2010.
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