Avastin fails to slow breast cancer: FDA

CBC News, 16 July, 2010

Federal health scientists said Friday that followup studies of a Roche breast cancer drug show it failed to slow tumour growth or extend patient lives, opening the door for a potential withdrawal in that indication.

The U.S. Food and Drug Administration (FDA) approved Roche's blockbuster Avastin in 2008 based on early-stage trials showing it shrank tumours caused by breast cancer. The decision was controversial because drugs for cancer patients who have never been treated before must usually show evidence they extend lives.

Avastin's so-called "accelerated approval" was based on the condition that later studies would show a survival benefit.

But in briefing documents posted online, FDA reviewers said two followup studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.

Read more: http://www.cbc.ca/health/story/2010/07/16/avastin-breast-cancer-trials.html#ixzz0u9QRrpe6