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Editor's note: In July 2010, an FDA advisory panel recommended that Avastin no longer be administered to breast cancer patients along with chemotherapy. Researchers on the panel found no meaningful benefit for patients who took Avastin and believed the toxicity of the drug outweigh positive effects. The FDA is expected to make a final decision about Avastin in September 2010.
The U.S. Food and Drug Administration (FDA) has approved the drug Avastin (generic name, bevacizumab) to treat advanced breast cancer with certain types of chemotherapy. The FDA's approval came as a surprise because its advisory panel recommended against approval, stating that Avastin had not been shown to increase patient survival. However, in approving the drug, the FDA noted that Avastin slows the progression of advanced breast cancer. The FDA approved Avastin to be used with chemotherapy that includes the drug Taxol in advanced breast cancer patients who have not undergone chemotherapy and whose cancers are not HER-2 positive. HER-2 is a protein found on the surface of breast cancer cells. Some breast cancer patients have extra copies of HER2 that can be associated with more aggressive or treatment-resistant cancers. Another drug, Herceptin, can be used to treat breast cancer patients with HER-2 positive breast cancers. Avastin works by attacking the vascular endothelial growth factor (VEGF) in tumor cells. VEGF enables tumors to grow their own blood supplies, which spur their growth. Avasin is already FDA-approved to treat advanced colorectal and lung cancers. An estimated 9,500 patients currently take Avastin with limited insurance coverage. A year's supply of the drug is estimated to cost around $100,000. Experts say that the FDA's decision not to follow its advisory panel's recommendation could open the door to future approvals that focus more on slowing the progression of a disease rather than increasing survival. However, others note that issues that the FDA's approval raises. Specifically, whether slowing the progression of cancer, without improving quality of life or survival time, is sufficient to approval cancer drugs. The National Breast Cancer Coalition noted that the FDA's approval of Avastin for breast cancer lowers the medical standards for cancer drugs. However, other organizations, such as Y-ME hail the FDA's decision, as it offers hope to cancer patients. Side effects of Avastin are similar to other cancer drugs and include bleeding, heart attack, stroke and other complications. Genentech, the maker of Avastin, is planning to apply for FDA approval of Avastin to treat renal cell cancer later this year.
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