Cancer Patients Petition The FDA Over Avastin
4 CommentsBy Ed Silverman // September 15th, 2010 // 8:28 am
As the FDA nears a decision on what to do about a metastatic breast cancer indication for Roche and Genentech’s Avastin medication, a growing number of people are petitioning the agency to maintain the status quo. Last month, you may recall, an FDA advisory panel recommended approval be withdrawn for treating breast cancer. The move came after two recently released studies - which were undertaken as a condition of approval - found that patients given Avastin and chemotherapy didn’t survive longer than those given chemo alone. Patients also suffered serious side effects.
Agency critics argue the indication should be yanked because the FDA based its decision on what they say is an inadequate endpoint - progression-free survival - and the FDA should have required more trials instead of granting accelerated approval (see this). But one woman - Christi Turnage, a registered nurse and breast-cancer survivor from Madison, Mississippi - recently started an online petition that has gathered some 6,500 signatures, which were just sent to the FDA in hopes of convincing the agency that the breast cancer indication for Avastin should be maintained (see the letter and names here).
Why? Avastin helped Turnage and, therefore, it holds out the promise of helping others. This is hardly the first time that a public plea was made to the FDA. Several weeks ago, US Senator David Vitter, a Louisiana Republican, wrote the agency to urge the indication be left in place. In any event, the video was made by her 19-year-old son, who explains their rationale.
Kaye Stevens
I feel that this is over a thousand times of my commenting on Avastin. But, as the decision times draws near I find myself feeling as if I am on “death row’ and my day of reckoning has arrived. I have been fighting MBC/stage 4, for over four years. I will not revert to the harsh chemo drugs. Forward Forever - Backward Never… Avastin should be on the market and available to me and any other person that would like it. Hopefully the FDA still stands for Food and Drug Administration - not Food and Death Administration. I demand the right to choose.
Insider
That would be nice if there was some evidence it worked.
Mary Pickett
As a surviver, and as I watch our Gov’t in utter disgust, send women to their graves for the sake of power and control–I Urge all American Walk for Life Groups that March and walk to provide donations to Cancer Research, to come together and all March on Washington. Let us have a Million Womens March and see if the Polititians and the FDA Goons get the message that life is a Natural Right given by God! Hopefully leaders of these groups can organize such a March!
industry insider
I agree with insider. Let’s talk science without the emotional overlay. As you can see in the key article below, VEGF receptor mutation overexpression (that’s what is targeted by Avastin) is present in only six percent of all malignant breast cancers, hence any clinical study is likely to show Avastin failure in the vast majority of cases. Even with EGFR positivity, VEGFR inhibitors are not a sure fire thing in this multifactorial disease.
http://www.nature.com/modpathol/journal/v18/n8/full/3800438a.html