Breast Cancer Action Disagrees With FDA's Avastin Ruling

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 26 Feb 2008 - 1:00 PDT

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Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration's decision giving accelerated approval to biotech company Genentech's application to market its drug Avastin as a treatment for metastatic breast cancer at this time.

"The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today's decision is a victory for drug companies, but not for patients," BCA Executive Director Barbara A. Brenner said.

BCA has long opposed Genentech's application, arguing that no evidence has been presented that shows Avastin improves overall survival or quality of life.

In its application to the FDA, Genentech said that a clinical trial indicated that Avastin prolongs progression-free survival. However, BCA argued - and continues to argue -- that that endpoint is meaningless because (1) it does not address the patient's quality of life during those additional months, a very real question because of some of the serious side effects a number of the women experienced, and (2) it has not been shown in this case to correlate with overall survival. The data from another trial done by Genentech's parent, Roche, has not been released, but it appears that it has the same limitations.

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.

Breast Cancer Action