Panel recommends Avastin be withdrawn from breast cancer market

breast.jpg

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

 

The information provided on CancerTreatment.net is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her health professional. This information is solely for informational purposes and does not constitute the practice of medicine. We encourage all visitors to see a licensed physician or nutritionist if they have any concerns regarding health issues related to diet, personal image and any other topics discussed on this site. Neither the owners or employees of CancerTreatment.net nor the author(s) of site content take responsibility for any possible consequences from any treatment, procedure, exercise, dietary modification, action or application of medication which results from reading this site. Always speak with your primary health care provider before engaging in any form of self treatment. Please see our Legal Statement for further information.