Panel advises FDA to reject Avastin as breast cancer drug

Jul 1 2011

The unanimous recommendation by this committee of cancer experts increases the likelihood that the drug will no longer be widely available for the treatment of breast cancer. Avastin, however, will continue to have the Food and Drug Adminstration's approval for use in treating certain other cancers.

The New York Times: Panel Advises FDA To Narrow Its Approval For Avastin
A resounding vote by a federal committee of cancer experts on Wednesday makes it more likely the drug Avastin will no longer be readily available as a treatment for breast cancer, dealing a blow to women who think the drug is helping them. In a series of 6-0 votes, an advisory committee to the Food and Drug Administration endorsed the agency's proposal to revoke the approval of the drug for use against advanced breast cancer (Pollack, 6/29).

Los Angeles Times: FDA Advisors Reject Avastin As Breast Cancer Treatment
The recommendation Wednesday came after two days of testimony from patients, doctors and advocacy groups. The panel heard several tearful accounts, like that of Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday (Mai-Duc, 6/30).

The Washington Post: FDA Panel Votes Against Avastin For Breast Cancer Treatment
A Food and Drug Administration panel took a major step Wednesday toward ending use of the best-selling drug Avastin for treating advanced breast cancer in the United States, despite appeals from distraught patients and the company manufacturing the drug. A crucial six-member FDA advisory committee unanimously concluded that the drug was harming women more than it was helping them. FDA Commissioner Margaret A. Hamburg must make a final decision, but agency commissioners usually follow advisory panel recommendations (Stein, 6/29).

NPR: Expert Panel Tells FDA To Pull Approval Of Avastin For Breast Cancer
In the end, Genentech failed to persuade a single member of the Food and Drug Administration's panel of cancer experts that its blockbuster drug Avastin should keep the agency's seal of approval for treating advanced breast cancer (Knox, 6/29).

The Wall Street Journal: Vote Is Defeat For Roche Cancer Drug
Roche Holding AG's rare challenge to the Food and Drug Administration over a drug decision fell short as an FDA appeals panel unanimously voted to revoke the accelerated approval of Avastin for breast cancer (Mundy, 6/30).

Marketwatch: FDA Panel Votes Down Avastin Breast Cancer Use
The drug, a widely used cancer treatment manufactured by Roche Holding AG's Genentech unit, is still approved for cancers of the colon, kidney, brain and lung. At the end of a two-day hearing, the panel voted 6-0 that there's not conclusive evidence the drug is effective, especially considering its side effects. Agency Commissioner Margaret Hamburg will make the final decision, but "we have not specified a time for her," FDA spokeswoman Karen Riley said in an email (6/29).