Genentech/ TDM-1 info for making your voice heard

[7andcounting]

Rep at Genentech told me today that they are documenting all calls that come in regarding women asking to get access to TDM-1. Currently there are only 12 states that offer this drug through Genentech's expanded access program. Genentech is currently working on a protocol amendment that would make TDM-1 avaliable in more states.

Please make your voices heard. Ask that Genetech make this drug avaliable for compasionate use. Ask that women in all states would have this drug avaliable to them.


GENENTECH 1-888-662-6728

Thank you!

[hutchibk]

I don't know for sure what the Rep meant, but Expanded Access Protocol (EAP) IS the same as compassionate use...

Here's a thread about what Genentech has already shared with us about this situation and the idea that they are tossing around...

http://her2support.org/vbulletin/showthread.php?t=50196

[7andcounting]

Hi, Thanks for the thread, I had read it.

My concern is that Genentech may only provide this drug to the women who are ---- currently on this trial---- letting them recieve it from their local oncologist. I am hoping women will call so they understand the great need there is for them to supply it to any woman who fits the criteria, even if that woman was NOT enrolled in the trial.

Traveling to the "closest" expanded access facility is not an option for me, therefore I won't be on this trial. So, according to what Genentech is proposing I would not be able to get this locally unless Genentech changes how they are currently writing up their ammended protocol to say.

Also, I talked to the nurse who was at the "closest" facility to me and she said this ----trial is closing ---in about 1 month.

[hutchibk]

In my understanding, there are no firm guarantees or decisions yet about how anything will change and when... but if you want in the T-DM1 EAP and you qualify, personally, I would get moving swiftly to get into it at one of the accruing locations. Things can change quickly, so it's better to be in process than left out in the cold.

It's not only a Genentech decision, but also in concurrence w/ the FDA I think. There is so much that goes into shifting and changing protocols of trials when you are working towards approval to get it to market... most especially how all of the data from the ongoing trials is combined together so as to help and not adversely affect the eventual outcome/decision.

[Pray]

Can someone tell me the 10 states that have the TDM-1 trial drug?

[schoonder]

Here's link to entry in clinicaltrials.gov registry re: specifics of T-DM1 expanded use trial.

http://www.clinicaltrials.gov/ct2/sh...xpanded&rank=1

[hutchibk]

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120561

Contacts
Contact: Trial Information Support Line 888-662-6728

Locations
United States, California Investigational Site Highland, California, United States, 92346
United States, California Investigational Site Stockton, California, United States, 95204
United States, Colorado Investigational Site Denver, Colorado, United States, 80220
United States, Florida Investigational Site Davie, Florida, United States, 33328
United States, Illinois Investigational Site Chicago, Illinois, United States, 60612
United States, Indiana Investigational Site Lafayette, Indiana, United States, 47905
United States, Iowa Investigational Site Cedar Rapids, Iowa, United States, 52403
United States, Kentucky Investigational Site Louisville, Kentucky, United States, 40245
United States, Michigan Investigational Site Detroit, Michigan, United States, 48201
United States, Missouri Investigational Site St. Louis, Missouri, United States, 63141
United States, South Carolina Investigational Site Charleston, South Carolina, United States, 29414
United States, Tennessee Investigational Site Nashville, Tennessee, United States, 37203
United States, Texas Investigational Site San Antonio, Texas, United States, 78229
United States, Virginia Investigational Site Fairfax, Virginia, United States, 22031

[Rich66]

Link to trial: http://clinicaltrials.gov/ct2/show/NCT01120561