The FDA advisory panel has just finished voting on the Avastin hearing. They voted on 2.5 questions. I am paraphrasing them here to keep the spirit of them but make them more clear.
Q1: Did the follow-on studies fail to verify the clinical benefit that was shown in the accelerated approval application?
Q2a: Has Avastin been shown to be effective in fighting MBC?
Q2b: Do the benefits of Avastin outweigh the risks for MBC?
Q3: Regardless of the outcome of the votes on the other questions, should it continue to be labeled for MBC while more trials are done?
No surprises on this one. Nothing Genentech presented moved the needle. They continue to recommend that the labeling for MBC be removed. The follow-on studies failed to verify the clinical benefit and the risks are significant. Genentech plans to move forward with further studies.
I applaud the FDA for sticking with the available science rather than being swayed by the sticky politics of this decision.
We deserve better from our drug companies than to be treated like ATMs.
4 comments:
In this case, I believe the FDA is correct in moving to withdraw approval for Avastin for use with metastatic breast cancer.
But for the patients who are currently receiving Avastin, if Genetech is so convinced of its efficacy for metastatic breast cancer, then it should work with the insurance companies to ensure these patients aren't penalized financially for their INFORMED decision to continue with the medication on an off-label prescriptive basis.
But as I understand it such an arrangement is outside of the FDA's sphere and the issue would then be between Genetech, the insurance companies and the patients.
In any case, all of this really points to the way in which the approvals process for chemotherapy drugs are stacked against metastatic treatments...see this letter to the editor of the NY Times....
To the Editor:
The issue can be reduced to a simple question: How does one define efficacy in cancer treatment?
One criterion for approval of anti-cancer drugs is lack of progression, and progression is based on an increase in tumor size over time. However, it is not tumor size per se that kills, but invasion and subsequent metastases, which are unrelated to tumor size.
The tumor-reduction paradigm has not delivered, and potentially beneficial drugs continue to be rejected if they do not block tumor growth. Unless “progression” is redefined as local invasion and metastases, the problem will remain.
In Greek mythology, Procrustes either stretched or cut his guests to make them fit the bed. Are we doing the same in cancer drug research?
MICHAEL FERNANDES
Chapel Hill, N.C., May 25, 2011
http://www.nytimes.com/2011/06/02/opinion/l02avastin.html?_r=2&ref=todayspaper
Thanks, Anna. I know emotions run high on this, and for good reason. If we really understood MBC, Avastin likely wouldn't have been given a conditional approval in the first place. We need surrogate endpoints that correlate with overall survival.
Katie
Katie,
I have a different take on this: what works in one case isn't the same as in another, and there definitely is a small percent of women who tolerate Avastin and who respond to it. Especially for some women with advanced, triple negative BC, there are few therapeutic options.
And based on my experience in oncology giving chemo drugs, I know that Avastin is no more toxic than most chemo agents; it's just that its side effects have been highlighted in the news this year, heavily. Most cancer drugs don't work in many or even most patients for whom they're prescribed.
The truth is that the medical science isn't so clear for many cancer treatments that are routinely prescribed. There was not a single BC specialist on the FDA panel.
The drug should be available as a treatment choice for women with MBC who choose it with informed consent, at least until better drugs come along.
Elaine,
Thanks for commenting.
First of all, the science is the science. If you are correct that Avastin works for some women, then the onus was on Roche to prove that. None of the studies show that Avastin has any positive impact on breast cancer.
Most importantly, this drug WILL still be available. No one has taken it off the market. The FDA panel has absolutely no impact on the availability of Avastin, so a woman with informed consent can continue to take it.
The FDA's job was to evaluate scientific studies and make a decision. The emotion of it is not their concern, nor should it be. I believe that they did their job, and correctly.
What we advocates should be doing is demanding drugs that actually work for MBC.
Katie
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