A Food and Drug Administration’s (FDA) advisory panel on Tuesday, July 21, recommended that the agency withdraw marketing approval of Avastin, a blockbuster breast cancer drug. The reason – the panel found that breast cancer patients saw no apparent benefit from taking Avastin.
The recommendation should not affect the drug being marketed for treating four other types of cancer -kidney, lung, colon, and brain cancers.
You may recall that Avastin received a fast-track approval from the FDA in February 2008. Part of that approval included a requirement to conduct post-approval clinical trials to ensure the drug was safe and effective.
In the clinical trial that brought the drug approval, Avastin was combined with the drug, paclitaxel, to be used in women with advanced or metastatic breast cancer. Women experienced a slowed progression of cancer, also known as progression-free survival for five months plus. The bottom line for these women was they did not gain more life however. Follow-up clinical studies have failed to replicate the initial findings. In fact, because of pharmaceutical medical complications from Avastin, survival was actually shorter for those taking it. The advisory panel voted 12 to 1 that the FDA should rescind marketing approval for Avastin.
That is bad news for Roche subsidiary, Genentech, the drug’s manufacturer. Genentech believes the drug should continue to be offered as one option for women. Since its approval, Avastin has been a blockbuster for the company, with annual sales of about $6 billion, making it the best-selling cancer drug. The FDA does not have to follow the advisory panel’s recommendations, but usually does, and is expected to issue a formal decision by September 17.
