FDA Seeks to Revoke Avastin Approval for Breast Cancer

Federal regulators announced today that they have begun the process of revoking approval of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avastin to treat advanced breast cancer. According to the US Food & Drug Administration (FDA), Avastin has not been shown to be a safe and effective treatment for advanced breast cancer

According to Reuters, Roche, the maker of Avastin, said it would request a hearing to contest the decision. If the FDA grants a hearing, there is no set date for when this would occur and until the procedure is concluded, Avastin will remain FDA-approved in breast cancer.

The FDA said it is recommending that the advanced breast cancer indication for the pricey cancer drug be revoked after reviewing the results of four clinical studies of Avastin in women with breast cancer. The agency said it determined that the data indicate that the Avastin 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. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July, an independent FDA advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

According to a statement from the FDA, the recommendation is only the first step in revoking Avastin’s breast cancer indication. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers, the FDA said.

Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in May 2009, it was approved to treat glioblastoma multiforme, an incurable brain cancer.

Avastin’s breast cancer indication was granted under an accelerated process that was based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s provisional approval for breast cancer was based on an initial trial that showed it lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount. When the FDA initially approved Avastin as a treatment for breast cancer, it did so against the recommendation of an advisory panel.

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