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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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