As expected, an advisory committee of the US FDA has recommended that the agency withdraw approval for Roche's blockbuster anticancer drug Avastin for the treatment of metastatic breast cancer.
The FDA initially granted accelerated approval for Avastin back in February 2008 for breast cancer, a status that permitted the drug to be marketed as a breast cancer treatment while simultaneously demanding that the drug maker continue to carry out added clinical trials to prove the drug's efficacy.
The advisory committee was unanimous in agreeing that the latest clinical trials fell far short of supporting the initial trial results, and the panel voted 12-1 that Roche should be required to end marketing of the drug to treat breast cancer. The FDA will make its final decision in the Fall. It is not beholden to the committee but generally tends to follow its recommendations.
The withdrawal could mean about $1 billion in lost revenue to Roche but it will not affect the drug's current FDA approval for other cancers.
By Ross Bonander
