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FDA Grants Hearing on Avastin in MBC

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123Donna View Drop Down
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    Posted: Feb 25 2011 at 1:49pm

FDA Grants Hearing on Withdrawal of Bevacizumab Approval in Metastatic Breast Cancer

Elsevier Global Medical News. 2011 Feb 24, E Mechcatie

The Food and Drug Administration has granted Genentech a 2-day hearing on the agency's plan to strip bevacizumab of accelerated approval for the treatment of metastatic breast cancer, the company announced on Feb. 24.Genentech, a member of the Roche group, has appealed the proposed withdrawal of the indication for bevacizumab (Avastin) in combination with paclitaxel (Taxol) as a first-line treatment of HER2-negative metastatic breast cancer.

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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kidzrn View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote kidzrn Quote  Post ReplyReply Direct Link To This Post Posted: Feb 28 2011 at 4:53pm
Thanks for posting this Donna....was planning to do so myself. I know most everyone has signed my petition and things are getting more intense now. The best way to communicate your thoughts concerning avastin are to post on the FDA Docket directly. I was really excited that to hear all 3 doctors that I heard speak at the C4YW say they were still prescribing Avastin and that it was actually really good for getting disease under control quickly (i didn't know that) and that there are many, trials still going on with Avastin. Dr. Edith Mitchell who spoke specifically on TNBC at the conference spoke of how well some of her patients have done and just encouraged us to voice our opinions. I had to slip out a couple of mins early to catch my flight so I don't know if she ever said how to voice your opinion so I thought I would share with everyone. We will not be allowed to speak at the hearing but many of us are going to DC June 28-29 if anyone wants to join in. This is not just about avastin but about our options and having our doctors who know us best, decide what is best for us. Anyway, here are the instructions to post on the FDA Docket:

*  Go to www.regulations.gov
* Input keyword:  FDA-2010-N-0621
* Scroll to the results box with a row titled "FDA/CDER to Genentech, Inc. - Letter"
(last one listed) , Click on the link on the right, Submit Comment
* when you submit a comment you must choose a submitter catagory: 
     ~If you are an advocate, part of a group or a healthcare professional, identifying yourself as    one means your comment will be publicly visible for others to read
     ~If you identify yourself as an individual consumer, your comment will be seen by the FDA but not by the public

Thanks everybody! This is really history making as hearings don't happen usually.......I believe this is the first hearing of its kind....

If you want to talk with me about anything concerning the docket, Washington, etc. you can PM me or email me at momfightingit@gmail.com

Thanks everybody!!! Christi

christi

2006,TNBC,Gr3 dbl mast, 4AC/4T {NED 4/07}, Lung Met 4/08, Carbo, Avastin, Taxol/Taxotere (CAT)x4, Lung Surgery 9/08, then Avastin every 3 wks until 2012...NED since 2/09
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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Mar 02 2011 at 8:01am
I read another article in the New York Times.  Here's the link to the article:

February 24, 2011, 4:23 pm

F.D.A. Grants Hearing on Avastin as Treatment for Breast Cancer

By ANDREW POLLACK

The Food and Drug Administration has granted a hearing for Genentech to argue in favor of preserving the approval of its drug Avastin as a treatment for breast cancer.

The hearing will take place June 28-29, the F.D.A. said in a letter
to Genentech’s lawyer and to a lawyer for the F.D.A.


http://prescriptions.blogs.nytimes.com/2011/02/24/f-d-a-grants-hearing-on-avastin-as-treatment-for-breast-cancer/?ref=health
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Sashaki View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Sashaki Quote  Post ReplyReply Direct Link To This Post Posted: Jul 02 2011 at 5:59am
A board of cancer professionals made a suggestion Wednesday on the narcotic Avastin. The panel determined that Avastin should not be authorized by the Food and drug administration for the remedy for cancer. The narcotic is unsuccessful and has severe side effects, the group determined. The Food and Drug Administration will make a final conclusion in July. I found this here: A panel recommends disapproving breast cancer drug
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