HER2 Support Group Forums - View Single Post - Lung mets suspected. I need info and support

heblaj01 · 10-12-2006, 01:39 PM

Linda,
You are right:Avastin is not yet approved for metastatic BC since Genentech
application for approval by the FDA is on hold until the manufacturer supplies more info on safety & efficacy based on the results of the clinical trials.
This may delay approval by about 12 months as commented in this press release:
http://www.gene.com/gene/news/press-...etail&id=10007

Monday, Sep 11, 2006
Genentech Receives Complete Response Letter From FDA for Avastin in Metastatic Breast Cancer

Your onc may nevertherless be willing to prescribe Avastin off label if he feels the clinical trials showed good outcomes.

10-12-2006, 01:39 PM	#12
heblaj01 Senior Member Join Date: Apr 2006 Posts: 543	Linda, You are right:Avastin is not yet approved for metastatic BC since Genentech application for approval by the FDA is on hold until the manufacturer supplies more info on safety & efficacy based on the results of the clinical trials. This may delay approval by about 12 months as commented in this press release: http://www.gene.com/gene/news/press-...etail&id=10007 Monday, Sep 11, 2006 Genentech Receives Complete Response Letter From FDA for Avastin in Metastatic Breast Cancer Your onc may nevertherless be willing to prescribe Avastin off label if he feels the clinical trials showed good outcomes.