Avastin On Trial

Tuesday, June 28, 2011 - 7:57am

FDA holds hearings on risks posed by drug used to treat terminal breast cancer.

In a rare move the Food and Drug Administration will hold a hearing today to allow a drug company to present its case to keep its cancer drug approved for terminal breast cancer patients.

The hearing comes after the agency revoked approval for such patients, saying drug risks outweigh any benefits for those patients.

Thousands of women say it has kept them alive, but a similar number have died while taking it.

Shannon Morgan is beating the odds.

She's a Stage Four breast cancer patient whose disease spread to her stomach.

She was treated with Avastin three years ago and has been in remission ever since.

"My life's normal," she now says.

Avastin was granted "accelerated approval" by the FDA in 2008.

This process gives cancer patients with few options access to potentially life-saving drugs under the condition ongoing studies show the drug is safe and effective.

Dr. Gary Lyman served as an advisor to the FDA.

"We wanted patients not to wait until final data was in to have access to this medication," he explains.

The studies that came in were not as promising.

They showed significant side effects without a survival benefit.

Last December the FDA revoked Avastin's approval for breast cancer, causing an uproar among the 17,000 women taking the drug and the doctors who treat them.

"I feel this drug certainly has activity, we've seen clinical benefit, and I'm worried for my patients' welfare," says Dr. John Powderly of the Carolina BioOncology Institute.

Avastin, if not covered by insurance, costs $90,000 per year.

Dr. John Powderly will testify during the two-day hearing at the FDA, along with Shannon Morgan and her husband.

"Avastin has really given me hope, and dignity, and the strength to carry on my life," Morgan says.

"Some panelists say the research is flawed, it needs more study, so let's do that, but keep it available while you do that," urges Pat Morgan.

What can't be misinterpreted in the data is how many women died of breast cancer while taking Avastin, putting the FDA in the tough spot of having to decide how to keep cancer patients safe while also giving patients like Morgan access to drugs that really do work for them.

Avastin is also approved for brain, lung and kidney cancer and will remain available to treat those diseases.

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