Avastin – breast cancer drug, fails to pass the FDA advisory panel vote on efficacy

By Dr. Ananya Mandal, MDJul 21 2010

According to a Food and Drug Administration (FDA) advisory committee’s (The Oncology Drugs Advisory Committee, or ODAC) recommendation this Tuesday, the marketing approval of the popular breast cancer drug, Avastin or Bevacizumab should be withdrawn. This decision followed the evidence from clinical trials that the drug was not effective. However the drug will continue to be sold for other cancers like those of brain, lung, colon and kidney. Avastin has a $6 billion market of which $1 billion comes from its use in breast cancer.

The approval for this drug was obtained on fast track on February 22, 2008 but this type of approval for a drug in a life threatening condition mandates further studies. The manufacturer is allowed to market the drug but needs to conduct additional clinical trials of the drug to demonstrate efficacy. Initial trials had shown that Avastin when combined with other breast cancer drug paclitaxel increased the time during which the therapy prevented progression of the disease — known as progression-free survival — by a little over five months compared with paclitaxel alone. The combination did not increase overall survival by a significant amount, however. After approval the new studies presented to the panel failed to confirm these initial findings. The progression free survival improved by little over one month and there was not benefits to overall survival and survival decreased in some participant. The panel voted 13 to 0 that the new studies failed to confirm the original findings and 12 to 1 that the agency should withdraw marketing approval of Avastin for breast cancer. The formal decision will be taken by September 17 by the FDA. Usually the recommendations of the panel are heeded in most cases.

Manufacturer Roche’s subsidiary Genentech, released a statement on Tuesday that the data was honest and that it believed that Avastin “should continue to be an option for patients with this incurable disease.” The company promised to work with the agency. Shares of Roche, which have already shed nearly 20% this year due to several drug pipeline failures, dropped 4.2% Wednesday.