HER2 Support Group Forums - View Single Post - Help me! Compassionate use exceptions needed for trial drugs NOW

schoonder · 06-22-2009, 05:11 AM

Carolyn,

I believe that if Roche(Genentech) agrees to supply you with the T-DM1 product, your oncologist can file an application to the FDA (form available on the net) for an "individual" IND. Of course the big question here:
is Genentech willing to work with you and for that matter, potentially thousand others in similar situations?
I believe that the company by now is sitting on tons of "interim" data results from T-DM1 trials still actively recruiting and ones no longer accepting volunteers that show how well this compound is performing.

06-22-2009, 05:11 AM	#34
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Carolyn, I believe that if Roche(Genentech) agrees to supply you with the T-DM1 product, your oncologist can file an application to the FDA (form available on the net) for an "individual" IND. Of course the big question here: is Genentech willing to work with you and for that matter, potentially thousand others in similar situations? I believe that the company by now is sitting on tons of "interim" data results from T-DM1 trials still actively recruiting and ones no longer accepting volunteers that show how well this compound is performing.