FDA Advisers Vote Against Avastin for Advanced Breast Cancer Treatment

June 30, 2011

FDA Advisers Vote Against Avastin for Advanced Breast Cancer Treatment

In three unanimous votes, the six members of the FDA oncology drug panel voted that Avastin is ineffective, unsafe and should have its approval for breast cancer treatment withdrawn, citing studies that have failed to show it is effective.
The recommendation Wednesday came after two days of testimony from patients, doctors, and advocacy groups.
The drug will remain on the market for various types of colon, lung, kidney and brain cancers, which are not part of the debate but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’t be able to afford the treatments, which can cost up to $100,000 a year.
Roche stands to lose up to $1 billion US in revenue for its bestselling product, which generates over $6 billion US per year assuming the FDA follows through on the withdrawal
The agency first approved Avastin in 2008 for breast cancer treatment under the agency’s “accelerated approval” process, which fast-tracks potentially life-saving drugs on a conditional basis.
Approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. Studies have shown the drug carries serious risks like high blood pressure, heart attacks, and bleeding.
The hearing was triggered after Genentech, a subsidiary of Roche, appealed an FDA announcement in December that it would withdraw its conditional approval of Avastin for breast cancer. It’s the first hearing of its kind for therapies green-lighted under conditional approval.
The final decision will be made by the commissioner of the F.D.A., Dr. Margaret A. Hamburg who is not obligated to follow the advice of the committee.

Publisher: Salient News

1 comment on “FDA Advisers Vote Against Avastin for Advanced Breast Cancer Treatment”

Medicare Will Continue to Cover 2 Expensive Cancer Drugs – New York Times | ehealthjournal.net

[…] against use of Avastin for breast cancerSan Francisco Chronicle33 KDAF-TV -kjrh.com -Salient Newsall 42 news […]

Comments are closed.