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

schoonder · 10-14-2010, 06:27 AM

The 3rd line MBC T-DM1 phase II trial TDM4374g, which started mid 2008 used by Genentech to file for priority review, wasn't the only evaluation of this drug in this patient population. A similar phase II trial in this setting, TDM4258g, that got underway in July 2007 also had very positive data.
Is it possible that participants in this trial did have prior experience with treatment options Genentech per FDA failed to include in trial for which NDA was filed and if so, couldn't that data, in conjunction with positive results from multi-national 1st line MBC TDM4450g trial be used for FDA to reconsider their decision?

10-14-2010, 06:27 AM	#73
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What can we do about the delay of TDM-1 The 3rd line MBC T-DM1 phase II trial TDM4374g, which started mid 2008 used by Genentech to file for priority review, wasn't the only evaluation of this drug in this patient population. A similar phase II trial in this setting, TDM4258g, that got underway in July 2007 also had very positive data. Is it possible that participants in this trial did have prior experience with treatment options Genentech per FDA failed to include in trial for which NDA was filed and if so, couldn't that data, in conjunction with positive results from multi-national 1st line MBC TDM4450g trial be used for FDA to reconsider their decision?