HER2 Support Group Forums - View Single Post - What can we do about the delay of TDM-1

chrisy · 09-07-2010, 08:41 AM

Well said, Brenda and Schoonder. And on point. I know you won't mind if I plagiarize

I think the FDA is applying old rules to a new game, and it just doesn't work.

When we say it to the FDA, cc your congresspeople and your newspapers. I'm working on my letter now. Just the other day, the FDA reversed position on another drug they were about to pull, based on overwhelming response.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Commissioner Margaret Hamburg, M.D.
301-847-3531 (fax)
margaret.hamburg@fda.hhs.gov

Deputy Commissioner Joshua Sharfstein
301-796-5040
joshua.sharfstein@fda.hhs.gov

Director Dr. Janet Woodcock
Center for Drug Evaluation and Research
Building WO51
Room 6133
Mail stop HFD-001
301-847-8752 (fax)
janet.woodcock@fda.hhs.gov

Director Richard Pazdur, M.D.
Office of Oncology Drug Products
Building WO22
Room 2212
301-796-9909 (fax)
richard.pazdur@fda.hhs.gov

Contacting congress:
http://www.contactingthecongress.org/

Also of note, check out the attached link to the petition re the FDA pulling Avastin. Could be another path to make our voices heard. Some of the issues are the same and we have many people on this board benefiting from Avastin who potentially could lose this also!
http://www.thepetitionsite.com/3/sto...breast-cancer/

09-07-2010, 08:41 AM	#40
chrisy Senior Member Join Date: Sep 2005 Location: Central Coast, CA Posts: 3,207	Re: What can we do about the delay of TDM-1 Well said, Brenda and Schoonder. And on point. I know you won't mind if I plagiarize I think the FDA is applying old rules to a new game, and it just doesn't work. When we say it to the FDA, cc your congresspeople and your newspapers. I'm working on my letter now. Just the other day, the FDA reversed position on another drug they were about to pull, based on overwhelming response. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Commissioner Margaret Hamburg, M.D. 301-847-3531 (fax) margaret.hamburg@fda.hhs.gov Deputy Commissioner Joshua Sharfstein 301-796-5040 joshua.sharfstein@fda.hhs.gov Director Dr. Janet Woodcock Center for Drug Evaluation and Research Building WO51 Room 6133 Mail stop HFD-001 301-847-8752 (fax) janet.woodcock@fda.hhs.gov Director Richard Pazdur, M.D. Office of Oncology Drug Products Building WO22 Room 2212 301-796-9909 (fax) richard.pazdur@fda.hhs.gov Contacting congress: http://www.contactingthecongress.org/ Also of note, check out the attached link to the petition re the FDA pulling Avastin. Could be another path to make our voices heard. Some of the issues are the same and we have many people on this board benefiting from Avastin who potentially could lose this also! http://www.thepetitionsite.com/3/sto...breast-cancer/ __________________ Chris in Scotts Valley June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?" 9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++ 10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response! 04/05 - 4/07 Herception every 3 wks, Continue NED 04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial 06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin 01/08 Progression in liver 02/08 Begin (TDM1) trial 08/08 NED! It's Working! Continue on TDM1 02/09 Continue NED 02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED 12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver 07/11 - 11/11 Herceptin/Xeloda -not working:( 12/11 Begin MM302 Phase I trial - bust:( 03/12 3rd times the charm? AKT trial 5/12 Scan shows reduction! 7/12 More reduction!!!! 8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!) 9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3 11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc 11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go. 2/13 Gemzar/Carbo/Herceptin - no go. 3/13 TACE procedure