Well, this is certainly a little odd.  Not only is it tough to get a drug through approval with the Food and Drug Administration of the United States, but it is very unusual to get a drug approved which has not already gotten the vote “yes” from the advisory panel that the FDA usually uses as a sounding board, and usually follows the consensus. 

This time with the cancer drug Avastin, the FDA has approved it for the treatment of breast cancer tumors against the advisory panel consensus.

This has some people worried, but also has some rejoicing since the drug has indeed been proven to shrink breast cancer tumors, but also has been known to have severely toxic side effects.  This time, they said they were surprised that the FDA approved the drug on tumor shrinkage vs. overall survival rate on the drug, which apparently was less than positive since everyone seems surprised the tumor shrinkage was used over the survival rate. 

Avastin has been prescribed in the US as an “off label” breast cancer drug, and has gained approval in other countries.  It is the biggest seller for drug maker Genentech, with revenue in the billions.  I have to be honest, I didn’t even know that doctors here in the US could still prescribe drugs that were technically not FDA approved as “off lable”, so I guess I learned something today by reading this article. 

I also must say that while it is great news this drug shrinks breast cancer tumors, it seems unfortunate that the survival rate is not as impressive as it’s tumor shrinking abilities.  This, overall, is worrisome to me, but that is just my opinion. 

This entry was posted on February 22, 2008 at 10:21 pm. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

Posted in Breast Cancer Prevention by Breast News Girl No Comments Yet