HER2 Support Group Forums - View Single Post - FRI DEC 17 - Genentech stakeholder call to discuss TDM1 (FDA) decision

StephN · 12-17-2010, 03:20 PM

Chrisy, I was also able to listen in as it was not too long. We met the doctors who moderated the call at the Genentech Advocates Reception on Thursday, Dec 9, in San Antonio.

It was quite heartening that the people from the Genentech side were really mixing with the attendees and making sure we knew each Gen. employee's position plus had their contact information.

MAIN POINT to note is that the European trials came out with THE OPPOSITE conclusions from Avastin data as our FDA. Gen. is seeking comments from the public/patients that will back up the European findings.

Another important point is that until the appeals process has gone its full route the drug is still approved for appropriate patients, including those getting it off label or with other drugs such as Xeloda.

There was a question from a woman from one of the Ovarian Advocate Groups. They are afraid that indication may also be on the chopping block. The Gen. oncologist, Dr. Horning, mentioned that there is also a phase III trial in progress with Avastin for brain cancer.

Perhaps since it is an expensive drug the FDA is wanting to limit its use to the best-responding cancers. Just a thought.

12-17-2010, 03:20 PM	#10
StephN Senior Member Join Date: Nov 2004 Location: Misty woods of WA State Posts: 4,128	Re: FRI DEC 17 - Genentech stakeholder call to discuss TDM1 decision Chrisy, I was also able to listen in as it was not too long. We met the doctors who moderated the call at the Genentech Advocates Reception on Thursday, Dec 9, in San Antonio. It was quite heartening that the people from the Genentech side were really mixing with the attendees and making sure we knew each Gen. employee's position plus had their contact information. MAIN POINT to note is that the European trials came out with THE OPPOSITE conclusions from Avastin data as our FDA. Gen. is seeking comments from the public/patients that will back up the European findings. Another important point is that until the appeals process has gone its full route the drug is still approved for appropriate patients, including those getting it off label or with other drugs such as Xeloda. There was a question from a woman from one of the Ovarian Advocate Groups. They are afraid that indication may also be on the chopping block. The Gen. oncologist, Dr. Horning, mentioned that there is also a phase III trial in progress with Avastin for brain cancer. Perhaps since it is an expensive drug the FDA is wanting to limit its use to the best-responding cancers. Just a thought. __________________ "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.