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

schoonder · 09-05-2010, 07:00 AM

If Roche files for T-DM1 approval by mid-2012 using Emilia's trial results, then earliest approval for this drug would be onset of 2013.

How about Congressional FDA Oversight Committee for those letters?

FDA refused to look at "any" of T-DM1's trial results because Roche failed to include "all possible" mbc therapies in this trial.
Since T-DM1 a "targeted" therapy has shown to be an effective treatment against HER2+ cancers, extending this trial, looking for candidates that failed those other "much less effective", thus "much less prescribed" treatment options, would've been a "waste of time".
However the FDA, overly risk averse, opted to use this omission, one that really had no bearing on trial outcome of HER2+ candidates, to issue a Refusal To File (RTF) letter. This RTF will delay approval of this very promising drug by at least two years.

09-05-2010, 07:00 AM	#7
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What can we do about the delay of TDM-1 If Roche files for T-DM1 approval by mid-2012 using Emilia's trial results, then earliest approval for this drug would be onset of 2013. How about Congressional FDA Oversight Committee for those letters? FDA refused to look at "any" of T-DM1's trial results because Roche failed to include "all possible" mbc therapies in this trial. Since T-DM1 a "targeted" therapy has shown to be an effective treatment against HER2+ cancers, extending this trial, looking for candidates that failed those other "much less effective", thus "much less prescribed" treatment options, would've been a "waste of time". However the FDA, overly risk averse, opted to use this omission, one that really had no bearing on trial outcome of HER2+ candidates, to issue a Refusal To File (RTF) letter. This RTF will delay approval of this very promising drug by at least two years.