HER2 Support Group Forums - View Single Post - Access to T DM-1

phil · 07-25-2011, 06:30 PM

genentech announced that they are closing the access program as of Sept. 6. Those already in it will be grandfathered in. They didnt say it, but its related to this FDA's fumbling of the development of t dm-1, a life-saving tx. A drug w/ the best stats coming out of Phase II trials , since Herceptin itself, 15 yrs before. This FDA denies approval of t dm-1 last Sept., recommending 3 more yrs of study, and approves Halaven the same month, a drug w/ much, much less impressive stats. I have nothing against halaven, but this FDA is burying its head in paperwork, refusing to see whats on tv. " Living Proof " , scores of women like Lorraine.Making us jump through more hoops, now its their new mantra , " Overall Survival ".
As research gets closer to winning the war on breast cancer , this FDA is losing it. Speak up !!

07-25-2011, 06:30 PM	#29
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: Access to T DM-1 genentech announced that they are closing the access program as of Sept. 6. Those already in it will be grandfathered in. They didnt say it, but its related to this FDA's fumbling of the development of t dm-1, a life-saving tx. A drug w/ the best stats coming out of Phase II trials , since Herceptin itself, 15 yrs before. This FDA denies approval of t dm-1 last Sept., recommending 3 more yrs of study, and approves Halaven the same month, a drug w/ much, much less impressive stats. I have nothing against halaven, but this FDA is burying its head in paperwork, refusing to see whats on tv. " Living Proof " , scores of women like Lorraine.Making us jump through more hoops, now its their new mantra , " Overall Survival ". As research gets closer to winning the war on breast cancer , this FDA is losing it. Speak up !!