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

schoonder · 10-15-2010, 11:52 AM

It appears a disconnect occurred between FDA and Genentech somewhere between first T-DM1 phase II trial for 3rd-line Her2+ MBC patients and second phase II trial which by design had greater emphasis on targeted aspects of prior treatments i.e. disease progression with both Trastuzumab and Tykerb/Xeloda regimens. What else could've been reason for conducting second phase II trial?

It's readily understandable that if T-DM1 showed efficacy where those prior targeted therapies, the ones most frequently prescribed because they heralded greatest promise to be effective, yet had now failed, that yes, a new life sustaining drug was brought into existence.

For Genentech to drag out their trial, searching for participants that had failed a number of infrequently prescribed treatments, ones not particularly suited for Her2+ MBC, i.e. lack of efficacy and high in toxicity, just to prove that T-DM1 was also superior to those regimens, wouldn’t that just be ludicrous?

Guess what, FDA totally failed to take into account targeted Her2+ aspect of this trial. Outdated directives didn’t provide FDA with an out to review T-DM1 3rd-line MBC Her2+ phase II trial results even though this agent clearly showed its pre-eminence over previously approved Her2+ targeted drugs.

10-15-2010, 11:52 AM	#75
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What can we do about the delay of TDM-1 It appears a disconnect occurred between FDA and Genentech somewhere between first T-DM1 phase II trial for 3rd-line Her2+ MBC patients and second phase II trial which by design had greater emphasis on targeted aspects of prior treatments i.e. disease progression with both Trastuzumab and Tykerb/Xeloda regimens. What else could've been reason for conducting second phase II trial? It's readily understandable that if T-DM1 showed efficacy where those prior targeted therapies, the ones most frequently prescribed because they heralded greatest promise to be effective, yet had now failed, that yes, a new life sustaining drug was brought into existence. For Genentech to drag out their trial, searching for participants that had failed a number of infrequently prescribed treatments, ones not particularly suited for Her2+ MBC, i.e. lack of efficacy and high in toxicity, just to prove that T-DM1 was also superior to those regimens, wouldn’t that just be ludicrous? Guess what, FDA totally failed to take into account targeted Her2+ aspect of this trial. Outdated directives didn’t provide FDA with an out to review T-DM1 3rd-line MBC Her2+ phase II trial results even though this agent clearly showed its pre-eminence over previously approved Her2+ targeted drugs.