FDA Panel Rejects Avastin for Breast Cancer

July 23, 2010

FDA Panel Rejects Avastin for Breast Cancer

An advisory committee Tuesday recommends the FDA withdraws marketing approval of cancer drug Avastin for the treatment of breast cancer, claiming that trials show no benefit from the drug.

If the FDA accepts this recommendation it would not affect the marketing of the drug for other types of cancer including brain, lung, colon and kidney cancer but would  prevent the manufacturer from promoting the drug for breast cancer treatment.

Initial approval of the drug for treatment was based on a clinical trial and issued in 2008. Avastin was combined with the breast cancer drug paclitaxel in women with metastatic breast cancer. The trial showed that the combination did increase the time of prevented progression. However the combination did not increase overall survival.

In a statement released on Tuesday the drug manufacturer Genentech a subsidiary of Roche, said that it stood by the data provided to the FDA and believes that Avastin “should continue to be an option for patients with this incurable disease.”  The agency is expected to make a formal decision by September 17. The FDA is not required to follow the recommendations of advisory panels, but that is often does.

At this time Avastin is the best selling cancer drug in the world.
About $1 of the $6 billion Avastin sales annually is thought to come from breast cancer treatment sales.

Publisher: Salient News

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