HER2 Support Group Forums - View Single Post - FDA finds Avastin doesn't extend lives in BC patients... ?

Debbie L. · 07-17-2010, 07:04 PM

Here's a link to the FDA website where you can see their documentation of the information that will be discussed at the ODAC meeting next week. http://tinyurl.com/3ys6hxb . Click on " Briefing Information for the July 20th . . ." in the first box. They have quite a detailed analysis of the two studies (AVADO and RIBBON1), some history of the drug, and a brief general discussion of treatment of metastatic breast cancer.

My sense is that Avastin is used a lot for 1st line HER2- metastatic treatment (and there are some adjuvant studies also), so a change in its (accelerated) approval status would be big.

But the bigger question here, as Crissy said, is about trial endpoints. Does a drug have to extend life to be worth using? What if it does not extend life, but by extending progression free survival it improves quality of life (fewer symptoms, fewer anxieties as progression happens and necessitates treatment changes, etc)? And then, what if it actually shortens life while improving quality (as some trends might indicate, in these studies)?

These end-point questions have not been answered by the FDA and those answers will have much longer-lasting impact than whether Avastin is approved for bc.

Another interesting part of this is that ODAC voted (5-4) AGAINST the accelerated approval, and the FDA granted approval anyway.

I don't know the answers. Frankly, depending upon who I'm talking to, I can be swayed either way. So wishy-washy. The argument against approval is that we must keep the bar high, so that drug companies will strive harder to offer better treatments, and so they do not think they can make fortunes with (very) marginally-effective products. The strongest argument for approval comes from those who say that quality of life is important too, and that at least for some, Avastin offers an improvement there. But even if we do agree that QOL should be part of the picture, these studies didn't measure quality of life. So can we infer it just because there was a little bit of PFS (plus lots more grade 3-5 SEs)? This dilemma makes it clear that if PFS is going to be an endpoint, QOL has to be included in the mix.

What a hard decision for ODAC and for the FDA.

07-17-2010, 07:04 PM	#5
Debbie L. Senior Member Join Date: Jul 2006 Posts: 463	Re: FDA finds Avastin doesn't extend lives in BC patients... ? Here's a link to the FDA website where you can see their documentation of the information that will be discussed at the ODAC meeting next week. http://tinyurl.com/3ys6hxb . Click on " Briefing Information for the July 20th . . ." in the first box. They have quite a detailed analysis of the two studies (AVADO and RIBBON1), some history of the drug, and a brief general discussion of treatment of metastatic breast cancer. My sense is that Avastin is used a lot for 1st line HER2- metastatic treatment (and there are some adjuvant studies also), so a change in its (accelerated) approval status would be big. But the bigger question here, as Crissy said, is about trial endpoints. Does a drug have to extend life to be worth using? What if it does not extend life, but by extending progression free survival it improves quality of life (fewer symptoms, fewer anxieties as progression happens and necessitates treatment changes, etc)? And then, what if it actually shortens life while improving quality (as some trends might indicate, in these studies)? These end-point questions have not been answered by the FDA and those answers will have much longer-lasting impact than whether Avastin is approved for bc. Another interesting part of this is that ODAC voted (5-4) AGAINST the accelerated approval, and the FDA granted approval anyway. I don't know the answers. Frankly, depending upon who I'm talking to, I can be swayed either way. So wishy-washy. The argument against approval is that we must keep the bar high, so that drug companies will strive harder to offer better treatments, and so they do not think they can make fortunes with (very) marginally-effective products. The strongest argument for approval comes from those who say that quality of life is important too, and that at least for some, Avastin offers an improvement there. But even if we do agree that QOL should be part of the picture, these studies didn't measure quality of life. So can we infer it just because there was a little bit of PFS (plus lots more grade 3-5 SEs)? This dilemma makes it clear that if PFS is going to be an endpoint, QOL has to be included in the mix. What a hard decision for ODAC and for the FDA.