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As Data Go Against Avastin For Breast Cancer, FDA May Yank Approval

Even miracle cancer drugs have their limits.

Avastin curbs growth of blood vessels that feed tumors. And sales of the medicine, made by Roche's Genentech unit, zoomed after it was shown to help many patients with colorectal cancer and later many other forms of the disease.

Now, though, the Food and Drug Administration is weighing whether to rescind approval of the medicine for breast cancer. Follow-up data on how patients have done since the agency gave the OK for Avastin to treat certain breast cancers two years ago cast doubt on the clinical value of the medicine.

In July, a panel of experts voted 12-1 to recommend that FDA take back the approval, a rare step, because the benefits don't outweigh the risks. As the Washington Post reports, the $8,000-a-month cost of Avastin for breast cancer has become a central issue.

Although FDA isn't supposed to weigh costs, the expense is hard to overlook. As breast cancer specialist Eric Winer at Boston's Dana-Farber Cancer Institute tells the Post, "For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs."

Even if FDA goes along with the experts' advice to yank approval Avastin for breast cancer, doctors would still be able to prescribe Avastin for that use. But, and it's a big but, insurers would be less likely to approve payment if the FDA decides the evidence doesn't back up Avastin.

The Avastin case also represents a test of how FDA deals with setbacks for drugs after they've been given speedy approvals based on preliminary data. A Government Accountability Office report last year faulted the agency for not be diligent enough in following up on those actions.

FDA has the power to withdraw approval of a drug if a company hasn't performed promised studies, or they don't pan out. But as of last September, the GAO noted, the FDA "has never exercised its authority, even when such study requirements have gone unfulfilled for nearly 13 years."

The FDA is expected to make a decision on Avastin by the middle of September.

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