Panel urges FDA to withdraw approval of Avastin for use against breast cancer

Wednesday, July 21, 2010


FDA urged to revoke breast cancer drug

Federal health advisers overwhelmingly urged the Food and Drug Administration to withdraw its approval for a breast-cancer drug after follow-up studies failed to show meaningful benefits for patients.

The panel of experts voted 12 to 1 Tuesday in favor of removing the drug's indication for use in breast cancer patients alongside chemotherapy. The FDA is not required to follow the group's advice, but it often does.

Avastin was approved for breast cancer in 2008, based on a trial showing it significantly lengthened the time until the disease worsened. But two follow-up studies recently completed by its manufacturer, Roche, failed to show the same ability to delay disease progression.

The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for a half-dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.

-- Associated Press

Insurance chief quits after rate-hike fight

The president of Anthem Blue Cross in California said Tuesday that she is resigning, three months after the company unsuccessfully attempted to raise rates on its customers, in the process becoming President Obama's poster child for out-of-control health-care costs.

Leslie Margolin led the insurer for more than two years. She said that she will go into health-care consulting.

In April, Anthem withdrew rate increases as high as 39 percent after drawing public outrage and rebukes from Obama. It now plans to raise premiums an average of 14 percent for individually insured policies, capping hikes at 20 percent.

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