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Patients plead to keep Avastin for breast cancer

By Anna Yukhananov

SILVER SPRING, Maryland (Reuters) - Breast cancer patients testified that Roche Holding AG's Avastin saved their lives as U.S. health officials consider whether the world's best-selling cancer drug should still be approved for that condition.

"I am alive due to Avastin," said 66-year-old Patricia Howard on Tuesday. "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.

FDA officials said the agency could review approval of Avastin for breast cancer after new studies, but it would be inappropriate to keep the indication as the studies would take at least three years.

For Switzerland-based Roche, the FDA decision could shave almost a billion dollars off Avastin's more than $6 billion in annual sales. Roche shares fell 0.4 percent in European trading on Tuesday.

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 rejection of the appeal could mean insurance companies would stop covering the expensive drug for breast cancer, potentially jeopardizing 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 will make its recommendation at the end of the hearing Wednesday, and FDA Commissioner Margaret Hamburg will later make the final decision.

LATER STUDIES LESS PROMISING

Avastin won U.S. clearance for breast cancer in 2008 based on a study showing the drug stalled cancer growth by 5.5 months when used in combination with standard chemotherapy. As part of an accelerated approval, the FDA required Roche to run follow-up studies to confirm the drug worked.

Later studies found only a one- to three-month delay in breast cancer growth. None of the studies showed Avastin extended the lives of patients with advanced breast cancer.

Some patients also had severe side effects, including holes in the stomach and intestines, severe bleeding and blood clots. The company says the incidence of these serious side effects was just under 3 percent greater for those taking Avastin.

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