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

schoonder · 01-31-2011, 07:44 AM

Phil,
Was thrilled to read that your wife in this short time span is responding so well to this relatively easy to tolerate drug and I can readily understand why many other patients having similar MBC characteristics would like to have access to this new agent.
There's something fundamentally very wrong with FDA's decision to on one data driven hand allow, yes maybe even encourage a 25 center extended trial to be conducted and on the other hand declare that this data from the 2nd phaseII trial, one that was necessitated because a recent approved Tykerb/Xeloda treatment changed trial option landscape, could not be looked at.
Drug's efficacy and tolerability and a good measure of common sense should be driving force behind FDA decisions.

01-31-2011, 07:44 AM	#14
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: Access to T DM-1 Phil, Was thrilled to read that your wife in this short time span is responding so well to this relatively easy to tolerate drug and I can readily understand why many other patients having similar MBC characteristics would like to have access to this new agent. There's something fundamentally very wrong with FDA's decision to on one data driven hand allow, yes maybe even encourage a 25 center extended trial to be conducted and on the other hand declare that this data from the 2nd phaseII trial, one that was necessitated because a recent approved Tykerb/Xeloda treatment changed trial option landscape, could not be looked at. Drug's efficacy and tolerability and a good measure of common sense should be driving force behind FDA decisions.