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Wednesday, June 29, 2011

Avastin for breast cancer

Patients plead to keep Avastin for breast cancer

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          U.S. health officials consider whether the world's best-selling cancer drug is approved for that condition of Breast cancer patients testified that Roche Holding AG's Avastin saved their lives.

          The great speak, "I am alive due to Avastin," said 66-year-old Patricia Howard on media "I'm a wife, mother, sister, aunt and granny. I'm not just a statistic. It's in your hands to make sure I don't become one."

          Patient testimony began the rare two-day meeting to hear Roche's appeal of the Food and Drug Administration's proposal in December to remove the breast cancer indication for Avastin.

At least 40 patients held signs and chanted outside the FDA building on Tuesday, wearing pink T-shirts with the slogan "We are statistically significant."

             FDA presenters said the agency had to follow the data.
"We cannot permit sponsors to evergreen approval of a drug that has not been shown to be safe and effective," Dr. John Jenkins, director of the FDA's Office of New Drugs, told the appeals hearing.

During the hearing, Roche unit Genentech is expected to argue the drug should be kept on the market pending new studies that show a more significant clinical benefit.

For patients, an FDA appeal could mean insurance companies would stop covering the expensive drug for breast cancer, potentially treatment for an estimated 17,000 women currently using the medicine.

Breast cancer is the second-leading type of cancer among women after skin cancer, with 1 in 8 women in the United States expected to develop invasive breast cancer over the course of their lifetime.

In 2010, an estimated 200,000 new cases of invasive breast cancer were diagnosed in the United States, and 40,000 women died from the disease.

The appeals panel recommendation at the end of the hearing  and FDA Commissioner Margaret Hamburg will later make the final decision

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