FDA panel says Avastin should not be marketed for breast cancer treatment


A Food and Drug Administration advisory committee Tuesday recommended that the agency withdraw its marketing approval of the blockbuster cancer drug Avastin for treating breast cancer, concluding that new trials showed no apparent benefit from the drug.

The action, if taken, would not affect marketing of the drug for brain, lung, colon and kidney cancer, but would prevent the manufacturer from promoting its use for breast cancer.

The agency issued a so-called accelerated approval of the drug for breast cancer on Feb. 22, 2008. That allows quick approval of a drug for a life-threatening condition, but also requires the manufacturer to conduct additional clinical trials of the drug to demonstrate efficacy.


The initial approval was based on a clinical trial in which Avastin, known generically as bevacizumab, was combined with the breast cancer drug paclitaxel in women with metastatic breast cancer. That trial showed that Avastin plus 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.

The new studies presented to the panel failed to confirm those initial findings. The progression-free survival improved by as little as a month and, again, overall survival did not improve. In fact, because of complications from the drug, survival was actually slightly less for some women. The panel voted 13 to 0 that the new studies failed to confirm the original findings and 12 to 1 that the agency should rescind marketing approval for breast cancer.

In a statement released Tuesday, the drug’s manufacturer, Roche subsidiary Genentech, said it stood by the data it presented to the FDA and that it believed Avastin “should continue to be an option for patients with this incurable disease.”

The agency is expected to make a formal decision by Sept. 17. It is not required to follow the recommendations of advisory panels, but generally does.

Avastin is the best-selling cancer drug in the world, with annual sales of about $6 billion. About $1 billion of that total is thought to come from sales for breast cancer treatment.