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

phil · 11-30-2010, 10:42 AM

This is my first post ever. My wife is a HER2 + patient, Stage IV since diagnosis in 2006. She is alive because of the advanced treatments we received at MGH in Boston. Earlier this year we were referred to Dana Farber for a new drug , Herceptin T DM-1. We were waiting to get it, when the FDA abruptly declined to approve it. ( Sept. 1) . It is not available in the Northeast, incl. NY. It's a long story, but the phar. co., Genentech has it at 13 sites elsewhere in the country. You can call them at : 888-662-6728, 9 A.M. - 6PM., EST. We have had to struggle to get it, and have finally received it in Virginia last week. We hear great things about it. It is the first " conjugate " , where Herceptin is paired up with a " toxin " ( chemo -like substance ) . Goes like a heat-seeking missile, only to the mutated cells . Few side-effects for many. Nothing is 100 %, but the Phase I, II data is very promising. Especially when you consider the alternatives for Stage IV HER2. So far my wife experiences only fatigue, and a low-grade fever. Three women we have met, have greatly benefited from the drug as well.
I cant talk too long at this point, but I wanted to get the word out. I am interested in talking with others who would like to advocate for this drug.
I definitely would recommend thast if you haveHER2 that has progressed on regular Herceptin, or especially if you have tried Tykerb/Xeloda, and it didn't work , or the side-effects were intolerable, that you talk with your doctor about this drug.
There are 2 " on paper " ways to get a non FDA-approved drug; "single patient access" or " expanded access" , If you call Gen, ask about " expanded access". Exp. access has only a 2 week " wash-out " period. ( Because of overall mild side-effects ) . There is no single -patient access at this time.It is also available in small clinical trials at Dana, ( and elsewhere) but we can't wait 3 months or longer to get in.
If the FDA would approve it ( which they should ) , we wouldn't jump through hoops... I'll have plenty to say about the FDA later...
Thanks, and God Bless...

11-30-2010, 10:42 AM	#1
phil Senior Member Join Date: Nov 2010 Posts: 393	Access to T DM-1 This is my first post ever. My wife is a HER2 + patient, Stage IV since diagnosis in 2006. She is alive because of the advanced treatments we received at MGH in Boston. Earlier this year we were referred to Dana Farber for a new drug , Herceptin T DM-1. We were waiting to get it, when the FDA abruptly declined to approve it. ( Sept. 1) . It is not available in the Northeast, incl. NY. It's a long story, but the phar. co., Genentech has it at 13 sites elsewhere in the country. You can call them at : 888-662-6728, 9 A.M. - 6PM., EST. We have had to struggle to get it, and have finally received it in Virginia last week. We hear great things about it. It is the first " conjugate " , where Herceptin is paired up with a " toxin " ( chemo -like substance ) . Goes like a heat-seeking missile, only to the mutated cells . Few side-effects for many. Nothing is 100 %, but the Phase I, II data is very promising. Especially when you consider the alternatives for Stage IV HER2. So far my wife experiences only fatigue, and a low-grade fever. Three women we have met, have greatly benefited from the drug as well. I cant talk too long at this point, but I wanted to get the word out. I am interested in talking with others who would like to advocate for this drug. I definitely would recommend thast if you haveHER2 that has progressed on regular Herceptin, or especially if you have tried Tykerb/Xeloda, and it didn't work , or the side-effects were intolerable, that you talk with your doctor about this drug. There are 2 " on paper " ways to get a non FDA-approved drug; "single patient access" or " expanded access" , If you call Gen, ask about " expanded access". Exp. access has only a 2 week " wash-out " period. ( Because of overall mild side-effects ) . There is no single -patient access at this time.It is also available in small clinical trials at Dana, ( and elsewhere) but we can't wait 3 months or longer to get in. If the FDA would approve it ( which they should ) , we wouldn't jump through hoops... I'll have plenty to say about the FDA later... Thanks, and God Bless...