HER2 Support Group Forums - View Single Post - Todays FDA hearing on Avastin,news from Genentech..

StephN · 06-29-2011, 03:37 PM

Hi -
I got a notice on this decision that had a link to Genentech's press release:
http://www.gene.com/gene/news/press-...etail&id=13528

The recommendation was for disuse with Taxol in HER2 negative patients.

The final decision will be made at a later date.

"the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin® (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer. The committee's recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision."

Need some clarification as to the standing for HER2 positive patients.

06-29-2011, 03:37 PM	#2
StephN Senior Member Join Date: Nov 2004 Location: Misty woods of WA State Posts: 4,128	Re: Todays FDA hearing on Avastin,news from Genentech.. Hi - I got a notice on this decision that had a link to Genentech's press release: http://www.gene.com/gene/news/press-...etail&id=13528 The recommendation was for disuse with Taxol in HER2 negative patients. The final decision will be made at a later date. "the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin® (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer. The committee's recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision." Need some clarification as to the standing for HER2 positive patients. __________________ "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. Last edited by StephN; 06-29-2011 at 03:41 PM..