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

schoonder · 09-07-2010, 06:17 AM

FDA will probably say that T-DM1 from what they have heard so far is a very effective, relatively easy to tolerate drug for Her2+ mbc patients. They will also say how disappointed they were that due to incomplete patient population in trial, they had to issue that RTF letter and that they are now anxiously looking forward to day that this issue is resolved so they can begin to evaluate the data.

I agree with hutchibk, focus should be on "judgment error" by FDA to take into account, or assign sufficient value to fact that Genentech moved this drug into clinic to provide new options, where few or none remained, for "strictly" Her2+ mbc patient population.
Underlying reason for RTF issuance "regardless of HER2 status" is totally misguided, yes, IT IS ALL ABOUT THE HER2 STATUS.
This trial by design was not for every patient suffering from metastatic breast cancer, this was a "targeted" approach, new medication for a small subset of patients. Targeted therapy, a somewhat new and upcoming process, shouldn't require that FDA look at how "all" approved mbc medicines compare to candidate drug. Participants in this trial had failed pretty much all treatment options that provided them with "any" chance of relief.
In a follow up study Genentech showed that T-DM1 was most efficacious on those candidates with strongest Her2+ expression.

09-07-2010, 06:17 AM	#39
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What can we do about the delay of TDM-1 FDA will probably say that T-DM1 from what they have heard so far is a very effective, relatively easy to tolerate drug for Her2+ mbc patients. They will also say how disappointed they were that due to incomplete patient population in trial, they had to issue that RTF letter and that they are now anxiously looking forward to day that this issue is resolved so they can begin to evaluate the data. I agree with hutchibk, focus should be on "judgment error" by FDA to take into account, or assign sufficient value to fact that Genentech moved this drug into clinic to provide new options, where few or none remained, for "strictly" Her2+ mbc patient population. Underlying reason for RTF issuance "regardless of HER2 status" is totally misguided, yes, IT IS ALL ABOUT THE HER2 STATUS. This trial by design was not for every patient suffering from metastatic breast cancer, this was a "targeted" approach, new medication for a small subset of patients. Targeted therapy, a somewhat new and upcoming process, shouldn't require that FDA look at how "all" approved mbc medicines compare to candidate drug. Participants in this trial had failed pretty much all treatment options that provided them with "any" chance of relief. In a follow up study Genentech showed that T-DM1 was most efficacious on those candidates with strongest Her2+ expression.