Avastin, manufactured by Genetech, is an injectable cancer medicine that was first approved by the FDA in 2004 for treatment of advanced colon cancer. It was subsequently approved for advanced lung, kidney and brain cancers. In 2008, the FDA gave Avastin accelerated approval for metastatic breast cancer treatment based on a single clinical trial. After the accelerated approval for breast cancer, Genetec completed additional trials and submitted the data to the FDA. In July 2010, an independent advisory committee voted 12-1 to remove the breast cancer indication.
In December, the FDA announced that it is recommending removing the breast cancer indication from the label for Avastin because the drug has not been shown to be safe and effective for that use. The recommendation was made after results of four clinical trials indicated that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. The risks include heart attack, stroke, severe high blood pressure, bleeding and hemorrhage, among others. The drug itself has not been removed from the market and will not have an immediate effect on its use in treating breast cancer.
Genetech has not agreed to remove the breast cancer indication voluntarily and has requested a public hearing to contest the FDA’s determination. If you need additional information you can contact Melissa Prickett, a lawyer in our Mass Torts Section, from our firm at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
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