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

schoonder · 03-13-2011, 08:36 AM

When FDA approved Tykerb/Xeloda protocol for MBC it changed landscape of available treatments.
At that time Genentech readily and willingly discontinued T-DM1 Her2+ 3rd line phase II trial that started in 7/07 and after implementing necessary alterations to account for this change, began a new evaluation (7/08). Yes, net result for pertinent MBC patients was a program delay of one year, but those are the rules, data presented to FDA must include latest treatment options for that disease. A possible benefit from conducting this second phase II is that FDA and Genentech had opportunity to sample results for not only a longer period of time, but also examine a much larger candidate population then they originally intended for this what was hoped to become a fast-track program.
So where are Genentech and FDA now? Well from Her2+ 3rd line MBC perspective they are at a two plus year standoff, because FDA refuses to evaluate the supplied data and Genentech isn’t willing to correct shortcomings identified by FDA for this particular trial. By mid-2012 company hopes to submit a new set of data from a currently worldwide ongoing trial in 2nd line Her2+ MBC (Emilia) and by doing this they also hope to receive approval in 3rd line setting.
This sums it up between Genentech and FDA, but where does this leave the thousands of patients that currently are identified being 3rd line Her2+ MBC, the ones that are so desperately in need of new, effective and easy to tolerate drugs? It looks like that patient population will be left carrying the bag. Usually in a standoff between parties they continue to get together to get differences resolved, when that after some finite period of time fails and subject matter is deemed of sufficient importance, arbitrators are assigned to bring matters to a fair conclusion.
Well, there are no continued talks, no arbitrators, guess subject matter isn't important, let’s do nothing, pull the rug out from under these sick people, let’s not give them opportunity to benefit from a potentially efficacious drug, let’s just remove all hope. Maybe this is could be conceived as a cruel and unusual punishment, but these patients are not criminals, so the 8th amendment of the U.S. Constitution doesn’t apply to them. Case is shut.

03-13-2011, 08:36 AM	#27
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: Access to T DM-1 When FDA approved Tykerb/Xeloda protocol for MBC it changed landscape of available treatments. At that time Genentech readily and willingly discontinued T-DM1 Her2+ 3rd line phase II trial that started in 7/07 and after implementing necessary alterations to account for this change, began a new evaluation (7/08). Yes, net result for pertinent MBC patients was a program delay of one year, but those are the rules, data presented to FDA must include latest treatment options for that disease. A possible benefit from conducting this second phase II is that FDA and Genentech had opportunity to sample results for not only a longer period of time, but also examine a much larger candidate population then they originally intended for this what was hoped to become a fast-track program. So where are Genentech and FDA now? Well from Her2+ 3rd line MBC perspective they are at a two plus year standoff, because FDA refuses to evaluate the supplied data and Genentech isn’t willing to correct shortcomings identified by FDA for this particular trial. By mid-2012 company hopes to submit a new set of data from a currently worldwide ongoing trial in 2nd line Her2+ MBC (Emilia) and by doing this they also hope to receive approval in 3rd line setting. This sums it up between Genentech and FDA, but where does this leave the thousands of patients that currently are identified being 3rd line Her2+ MBC, the ones that are so desperately in need of new, effective and easy to tolerate drugs? It looks like that patient population will be left carrying the bag. Usually in a standoff between parties they continue to get together to get differences resolved, when that after some finite period of time fails and subject matter is deemed of sufficient importance, arbitrators are assigned to bring matters to a fair conclusion. Well, there are no continued talks, no arbitrators, guess subject matter isn't important, let’s do nothing, pull the rug out from under these sick people, let’s not give them opportunity to benefit from a potentially efficacious drug, let’s just remove all hope. Maybe this is could be conceived as a cruel and unusual punishment, but these patients are not criminals, so the 8th amendment of the U.S. Constitution doesn’t apply to them. Case is shut.