Link to FDA review of Avastin
 

Link is below:

http://www.nytimes.com/2007/12/03/bu...l?ref=business

Interesting article.
I was a bit surprised at the part where the time to progression or death was not viewed as significant. Guess they need some people to stay in remission, and we may hear from same people here who are using Avastin to see how they feel about the drug.

My friend here who took it has over a year now with her troublesome nodes clear after Avastin/Abraxane.

Hi Stephanie,

I hope you're well.

I read it differently, that the FDA was more concerned with survival statistics and not progression statistics. In this article or another, I thought the FDA found that those taking Avastin with taxol progressed more slowly than those on taxol alone, but that survival rates for the two groups were not significantly different.

But I posted the link as I thought the article might be of interest. I am not of one view or another. I'd probably take anything my doctor told me would prolong my life if I could afford it, or my insurance would pay.

Would you know, by the way, when the herceptin patent is finished. Couldn't find it on the web. I'm wondering when the price will come down for those of us who might want to stay on it for life.

Avastin with Abraxane sounded to be an even more promising combo when I was at the Mets Conference at MD Anderson a few weeks ago. But, I don't think Abraxane is approved until Taxol has failed, yet Abraxane is proven to be quite superior to Taxol in everyway... it just seems like a never ending series of chasing our tails.

And I was denied Abraxane due to price, and yet the insurance company gladly pays for the Avastin...I am at least glad I am getting it with a Taxane and that so far it is doing its job...but then I have been on it for almost 7 months now...don't know what will happen when I go off....if it is like other combos, the nodes will rear their ugly heads! I hope not....for once...I can only dream of the day that I don't have to go for treatments....! Hmmmmmmmmmmmmm

hi sheila...was reading your post...how long will you be on taxol? Is there a set cycle. Sorry if i'm being nosey just curious. How are ya? hows the port. Mine looks fine no time to think about it since i've been to busy with steroids..lol
suzanne

Suzanne
I think the plan is at least 9 mos on the Taxol Avastin...the Herceptin I have been on for over 4 years. So far, I am in my 7th month of this combo....so by the end of March maybe a break. The port is doing great, I will change the dressing Thursday...I only get the steroids the day of infusion...IV. Are you on them all the time?

Grace wrote:
"I read it differently, that the FDA was more concerned with survival statistics and not progression statistics. In this article or another, I thought the FDA found that those taking Avastin with taxol progressed more slowly than those on taxol alone, but that survival rates for the two groups were not significantly different."

I think we both got the same conclusion out of that article, and why I mentioned that the FDA wants to see some remissions on that combo, rather than just increased survival time. Other drugs for stage IV have had a more lenient view for acceptance.

Regarding your question on the patent exclusivity, I put the question to Joe. He reminded me that drug patents are usually for 13 years, and probably granted about 1 year prior to FDA approval. I guess this means the initial approval, which was for stage IV patients and given around 1998 or so.

Maybe Joe or someone can delicately inquire on this point at San Antonio.

hey sheila,
i really hope you get a break...how have you found the seven months. I only get the steroids on day of then next 2 days. i think they could perhaps adjust the dose but then again maybe not. i will not be taking maxeran again!! take care good luck
suzanne