The bell continues to toll for Avastin, Genentech's blockbuster anticancer drug treatment: an FDA panel has voted 12-1 to remove its approval for the treatment of HER2 negative metastatic breast cancer, citing a handful of studies that show the drug failed to extend survival time for this patient population while simultaneously subjecting them to serious side effects.
Genentech has 15 days in which to request a public hearing. It is expected that they will do so, since if they do not, the FDA will move forward. Losing this indication could cost the biotech firm billions in revenue.
It wasn't the best of summers for Avastin:
In late July, an advisory committee for the FDA got this whole ball rolling when they recommended the drug's labeling be changed to omit treatment for metastatic breast cancer.
Then in late August, the UK's National Institute for Health and Clinical Excellence (NICE) rejected the treatment for advanced colorectal cancer, citing unconvincing trial data and excessive costs.
The FDA gave accelerated approval to Avastin in treating metastatic breast cancer in 2008. This approval is designed to allow early patient access to the treatment while further clinical trials are carried out.
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.
