QuoteReplyTopic: FDA Grants Hearing on Avastin in MBC 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
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
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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