For Immediate Release
Contact: Mary DeLucco
Breast Cancer Action
415.243.9301 xt 16
Breast Cancer Action
415.243.9301 xt 19
San Francisco, CA—Breast Cancer Action (BCA) today applauded the recommendation by a Food & Drug Administration advisory committee to deny biotech company Genentech’s application to market its drug Avastin as a treatment for metastatic breast cancer. The recommendation now goes to the FDA commissioner, who will make a decision in February 2008.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made its recommendation today after a public hearing, in which it heard from both supporters and opponents of the application.
BCA opposed Genentech’s application in a letter to the committee, urging that the request be denied if the company failed to show that Avastin improved overall survival. The committee agreed, indicating that because Avastin did not prolong survival or improve quality of life, the toxic side effects outweighed the benefits of the drug.
“We look forward to the day when Avastin is shown to be a good drug for women with breast cancer. But using measures of effectiveness like time to progression, which was used by Genentech for this drug, are meaningless unless that end point is shown to correlate with overall survival,” BCA Executive Director Barbara A. Brenner said. “We hope that today’s recommendation is the first step in changing the FDA’s standards for approval of breast cancer drugs.”
BCA was also opposed to Avastin being marketed as a breast cancer drug because of its cost. If Avastin had been approved for the treatment of breast cancer, the company indicated it would charge approximately $100,000 a year for the drug. It was estimated that the company’s sales would have increased by $1.3 billion.
This is the second time Genentech has requested approval to market Avastin as a breast cancer drug. When the company submitted an application in 2006, the FDA requested more thorough, independently reviewed data before considering the request.
Avastin is currently approved for treating advanced colon cancer and non- small-cell lung cancer.
Breast Cancer Action is a national watchdog and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic.
Since 1998, BCA has refused to accept funds from corporations that may create a real or apparent conflict of interest for BCA. Corporations covered by this policy include pharmaceutical companies.