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FDA considers yanking drug Avastin from market

June 28, 2011 12:00:00 AM PDT
It's the best-selling cancer drug in the world, but Monday the Food and Drug Administration held a hearing on whether to take Avastin off the market. Patients and doctors appeared before the government panel hoping to keep Avastin available.

When it was first introduced, Avastin was considered a wonder drug. Many breast cancer patients believe it's keeping them alive.

At an unprecedented two-day meeting at the FDA, the pharmaceutical company Roche is making a last-ditch effort to keep Avastin available to these patients.

Five years after she was diagnosed with breast cancer, Pat Howard said she can't believe she has to beg for the drug she says is keeping her and many other women alive.

"Due to Avastin I'm experiencing a quality of life that is nothing short of miraculous," said Howard.

Doctors and patients like Howard made personal appeals to the FDA to keep the breast cancer drug Avastin available to them.

The drug was approved in 2008 to treat advanced-stage breast cancer that has spread to other parts of the body.

"I believe that Avastin coming off the market would be devastating to my best cancer patients," said oncologist Dr. Stanley Waintraub.

Roche is challenging an earlier 12-to-1 vote to revoke the approval of Avastin as a breast cancer treatment.

The concern is over its effectiveness and side effects like holes in the stomach and intestines, severe bleeding and blood clots.

Breast cancer specialist Dr. Deanna Attai believes Avastin should not be counted out just yet.

"There are still clinical trials that are evaluating their data and analyzing their data," said Attai. "So I think that it does make sense to keep it available at least until we have more clinical data, because there are potentially patients that could benefit from this."

"We believe we need more effective and less-toxic treatments," said Vernal Branch, a breast cancer patient.

The FDA said Avastin neither extends nor improves life for breast cancer patients but it can still be used to treat other cancers.

Nearly 100,000 women have used Avastin. Pat Howard has used the drug for four years.

"Please approve Avastin as a treatment for my disease," said Howard. "What if I was your wife, your mother, your sister, your friend? And what if I was your grammy?"

If the FDA pulls the plug on Avastin, doctors could still prescribe it but insurance companies wouldn't cover it. One year's treatment can run more than a $100,000.


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