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FDA AVASTIN

November 19, 2011 by staff 

FDA AVASTIN, To the despair of some critically ill patients, a federal agency on Friday revoked its approval of Avastin for treating breast cancer after determining the widely used drug developed by South San Francisco-based Genentech fails to help patients live longer and causes life-threatening side effects.

The decision by the U.S. Food and Drug Administration to yank Avastin’s approval for treating breast cancer that has metastasized — spread to other parts of the body — creates uncertainty for hundreds if not thousands of women who believe Avastin has helped them or might in the future.

“I am just really sick about it; it’s so heartbreaking,” said 74-year-old Oakland resident Heraleen Broome, who has been taking Avastin since her breast cancer spread to her lungs in 2003. She said she fears for “these young women who come along and need Avastin and can’t get it.”

But many experts, including Karuna Jaggar, executive director of San Francisco-based Breast Cancer Action, praised the FDA for acting against a drug that gave patients false hope.

“There was a lot of hope and a lot of hype in Avastin’s initial conditional approval,” Jaggar said. Unfortunately, she added, that optimism has since been found to be unwarranted.

Because the drug still has the FDA’s blessing for treating certain types of colon, lung, kidney and brain cancer, doctors can use their discretion and prescribe it for breast cancer. But it’s unclear how many physicians will do that, given the FDA’s concerns.

In addition, while Medicare has said it will continue to cover the drug’s cost for breast cancer patients — which runs about $100,000 a year — at least one private insurer already has balked at paying for it.

Avastin was approved for breast cancer in February 2008, under an agency program that gives critically ill patients access to certain drugs while studies of the medications are still under way.

At the time, initial Genentech research showed that Avastin, when used with a chemotherapy drug, seemed to delay the growth of tumors and patient deaths. But after its approval, additional studies “showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone — not enough to outweigh the risk of taking the drug,” the FDA concluded.

Avastin’s potential side effects include severe high blood pressure, bleeding, heart failure and the development of perforations in the nose, stomach, intestines and other tissue.

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