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FDA Panel Votes to Revoke Avastin Breast Cancer Indication

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A Food & Drug Administration (FDA) advisory panel said yesterday that Avastin’s approval as a treatment for breast cancer should be revoked. The panel voted overwhelmingly against Avastin as a breast cancer treatment, by a margin of 12 to 1.

As we’ve reported previously, Avastin’s breast cancer indication was granted in 2008 under an accelerated process that is based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s breast cancer approval was based on an initial trial that showed lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount.

Two studies done since then failed to show the same ability to delay disease progression, the Associated Press said. The studies also showed more side effects among women being treated with Avastin.

The FDA is not required to follow the recommendations of advisory panels, but it usually does so. However, when it initally approved Avastin as a treatment for breast cancer, it a did so against the recommendation an advisory panel.

Even if Avastin’s breast cancer approval is rescinded, it will be allowed to remain on the market for its other indications. Roche would only be barred from promoting it as a breast cancer treatment. However, doctors could still continue to use Avastin to treat the disease, as they are free to use approved drugs in any way they see fit.

Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. Avastin was first approved by the FDA 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 is now the world’s best selling cancer drug, and the biggest seller for its maker, Roche.

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