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StephN · 04-14-2010, 11:34 AM

This is the part of the above letter from Breast Cancer Action that I don't understand AT all:

"We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial.

The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market,"

I have not heard that there even IS "expanded access" to this drug. Joe or anyone heard of the referred to "Expanded Access Study??"

And BCA is in "conversation with the sponsor" about expanded access??

04-14-2010, 11:34 AM	#18
StephN Senior Member Join Date: Nov 2004 Location: Misty woods of WA State Posts: 4,128	Re: BCA fighting to keep tdm1 off market This is the part of the above letter from Breast Cancer Action that I don't understand AT all: "We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial. The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market," I have not heard that there even IS "expanded access" to this drug. Joe or anyone heard of the referred to "Expanded Access Study??" And BCA is in "conversation with the sponsor" about expanded access?? __________________ "When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau Live in the moment. MY STORY SO FAR ~~~~ Found suspicious lump 9/2000 Lumpectomy, then node dissection and port placement Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR - Adriamycin 12 weekly, taxotere 4 rounds 36 rads - very little burning 3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED! 2003 & 2004 no active disease - 3 weekly Herceptin + Zometa Jan 2005 two mets to brain - Gamma Knife on Jan 18 All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying Continue as NED while on Herceptin & quarterly Zometa Fall-2006 - off Zometa - watching one small brain spot (scar?) 2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava 2008 - Brain and body still NED! Port removed and scans in Dec. Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011 STILL NED everywhere in Feb 2014 - on wing & prayer 7/14 - Started twice yearly Zometa for my bones Jan. 2015 checkup still shows NED 2015 Neuropathy in feet - otherwise all OK - still NED. Same news for 2016 and all of 2017. Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.