Avastin Drug For Cancer Rejected?

Avastin, the drug for cancer was rejected today.
Avastin is a drug approved to treat colon, lung, and other cancers. While it is approved in the European Union to treat breast cancer, the same indication has only been provisionally approved in the U.S. And now it is rejected.
What are the reasons behind Avastin's rejection in the United Stated?

asked by Electra in Drugs & Medicine | 1941 views | 07-21-2010 at 04:48 PM

The Oncology Drugs Advisory Committee, or ODAC, of the U.S. Food and Drug Administration, or FDA, Tuesday voted against a broader label for Avastin and recommended the FDA to revoke the provisional approval for the breast-cancer indication due to a lack of benefit when compared to the drug's risks.

The action, if taken, would not affect marketing of the drug for brain, lung, colon and kidney cancer, but would prevent the manufacturer from promoting its use for breast cancer.
The news is the latest blow for Avastin, which stumbled at key hurdles this year when it failed in late-stage stomach and prostate cancer studies.

The effectiveness of Avastin in advanced breast cancer was based on an improvement in PFS, but the U.S. panel wanted evidence that Avastin improved the overall survival rate.

answered by Troy | 07-21-2010 at 04:49 PM

comment
Thread Tools
vBulletin® Copyright ©2000 - 2014, Jelsoft Enterprises Ltd.