HER2 Support Group Forums - View Single Post - What can we do about the delay of TDM-1

schoonder · 01-05-2011, 11:27 AM

Michka, I believe that early 2013 is a very realistic timeframe to see T-DM1 approved in USA. Roche has indicated that they now will use progression free survival data from international her2+ mbc phase III trial Emilia, that compares this agent against Tykerb/Xeloda for approval purposes and that they expect to have this data available for FDA by mid-2012. If company can meet this schedule and if FDA is satisfied with overall contents of package and is able to complete review of this application within their usual timeframe, then yes, oncologists could be able to acquire this agent in 2013. Maybe bureaucrats in Europe will be somewhat faster in getting product's paperwork processed once Roche applies for approval over there.
I still maintain that FDA's RTF letter, their refusal to look at the data, should be reversed. Agency is 100% in the loop of development status of this agent which by now has progressed into two large phase III trials and which the FDA with much earlier phase II results had no problems with, to see it prescribed for those very needy in a compassionate use fashion.

01-05-2011, 11:27 AM	#83
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What can we do about the delay of TDM-1 Michka, I believe that early 2013 is a very realistic timeframe to see T-DM1 approved in USA. Roche has indicated that they now will use progression free survival data from international her2+ mbc phase III trial Emilia, that compares this agent against Tykerb/Xeloda for approval purposes and that they expect to have this data available for FDA by mid-2012. If company can meet this schedule and if FDA is satisfied with overall contents of package and is able to complete review of this application within their usual timeframe, then yes, oncologists could be able to acquire this agent in 2013. Maybe bureaucrats in Europe will be somewhat faster in getting product's paperwork processed once Roche applies for approval over there. I still maintain that FDA's RTF letter, their refusal to look at the data, should be reversed. Agency is 100% in the loop of development status of this agent which by now has progressed into two large phase III trials and which the FDA with much earlier phase II results had no problems with, to see it prescribed for those very needy in a compassionate use fashion.