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 called on the Food & Drug Administration to deny biotech company Genentech’s application to market its drug Avastin as a treatment for metastatic breast cancer.
The FDA’s Oncological Drugs Advisory Committee (ODAC) is scheduled to hold a hearing Wednesday on whether to approve Genentech’s request.
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.
BCA is urging the FDA to deny approval if no benefit in overall survival is shown. To date, the data Genentech has made available indicate that Avastin delays time to progression of metastatic disease, but there is no indication that it improves patient survival. The use of surrogate end points like time to progression, which are used as an early indicator of a drug’s effectiveness, are meaningless unless that end point is shown to correlate with overall survival.
“BCA looks forward to the day when we can say with confidence that a drug is effective at increasing survival for women with metastatic breast cancer. However, approving Avastin based on the kind of evidence currently available makes very sick women guinea pigs for evaluating the long-term effects of the drug, as well as its dangers,” says BCA Executive Director Barbara A. Brenner.
Avastin is currently approved for treating advanced colon cancer and non- small-cell lung cancer. If approved for treatment of breast cancer, Genentech has indicated it will charge approximately $100,000 a year for the drug. It is estimated that Genentech’s sales could increase by $1.3 billion.
Breast Cancer Action is calling for the regulation of biotech therapy prices so that everyone who might benefit from a drug can obtain it.
Breast Cancer Action is a national grassroots education 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.