For those of you on the extended TDM1

[fullofbeans]

Is it still considered as a "trial" i.e. do they provide the drug free of charge & do they collect the data??

Just curious

[Kathy T]

yes it is still a trial--the drug remains free. The drug co. dictates the rules.
Kathy T

[chrisy]

I ran into my study buddy last week at the lab...she is still on the extension study, now at 4 years on tdm1!!!!

[fullofbeans]

working for 4 years..music to my hear.. it is interesting to know I just wonder why they are not so keen to have EAP and why it represent such a risk investment if it is like a trial..

[chrisy]

Roche's number one priority is to get this drug approved. The barriers dropped in front of this process have been incredible - unconscionable some might say. The decision to close the EAP was a difficult and painful one (certainly for patients!) but was made in the interest of getting access for everyone via FDA approval.

That approach has manifested itself in the design of trials with 2/3 randomization to TDM1, and the opening of multiple large phase 3 trials.

One of the most perverse consequences of the FDA requirement to provide overall survival data is that it basically precludes anyone who has been in a TDM1 trial in a control arm from being allowed to get it later, say in an EAP. If everyone in a control arm (no TDM1) and had progression then subsequently got TDM1 and it worked, they would never be able to show a survival benefit and thus gain approval.

One very cool thing is the pertuzumab/TDM1 trials. In those, you may or may not get pertuzumab, but you definitely get TDM1, so a very likely winner in either case!

[fullofbeans]

Chrisy, thank you very much for the clear explanations. Indeed a perverse demand by FDA and I do wonder why this could not simply be done on referential data prior to TDM1, there must be a lot of data available for how long someone lives once metastatic, progressive and with Her2.

I cannot see that trial anywhere tdm1+/-pertuzumab but indeed it sounds good Is this in the pipeline?

[phil]

Lorraine is now on the t dm-1 extension. Gen. pays for drug. Its a " trial ' , but since This FDA refuses to let gen. use the expanded access or extension data ( like Lorraine doing well 16 months since being at deaths door step), the data wont count. As others have said This FDA's obstruction of accelerated approval , thier slowing down , pushing for lengthier overall survival stats is criminal. Killing pts. Will be investigated. It will be the Legacy of Pres. Obama : Losing The War on Breast Cancer, Putting A Cost on a Human Life ( Avastin, T DM-1 ? )... while spending trillions on wars...

[phil]

The pert/ tdm-1 / taxol trial is at Sloan in NY, Farber in Boston. everyone gets t dm-1, low dose , which helps avoid platelet issues. taxol gets dropped after 3mos if you respond. The pert is 50/50 randomized , but we see great results w/ just initial taxol , and low dose , weekly t dm-1. W/o pert. pert sounds good, but its not achemo. t dm-1 is already proven. its " the bomb", literally, for strong her2. The rumor mill says that pert's approval may be conditional, for early stage ? That would be CRAZY on This FDA's part. I've already written them . I think "Dr. " Pazdur and his t dm-1 " advisors " should be removed, they are completely un-able to make rational decisions about these 2 drugs.
On another note, someone form the UK , says T DM-1 should be approved soon, a few months ?, quicker than here. What else is new ? Now, that's a Good Rumor !

[radiant]

Phil /

Not receiving access to Pertuzamaub
For stage IV is criminal. What do we need
to do - die in someones office? It's getting
to that point!

Kim

[radiant]

http://www.roche.com/media/media_releases/med-cor-2012-02-08.htm

The above article for priority review on
Pertuzamaub states for 1st line and those
that have failed adjuvant therapy. I believe
the failure clause allows access to
Mets pts.

Kim

[schoonder]

Stockton, Cal and Plantation, Fla centers now partaking in T-DM1's expanded access program.
http://clinicaltrials.gov/show/NCT01120561

[radiant]

Schoonder -

Bless You! I just found out I progressed
yesterday. When I saw your posting, I
could not believe my eyes!!!

I called Stockton - they believe I qualify and
I have appt next week with them!

Hugs,

Kim

['lizbeth]

Kim,

What a wonderful blessing to find that post! I hope you qualify and it is very effective for you.

[Sandra in GA]

This site is wonderful! I just met another HER2 sister and I told her about the wealth of information one can learn from the very intelligent and informed members. You ALL are great!!

[phil]

Chrisy , I wish your study friend with 4 yrs would join our activist group. next time you see her ask if she would contact me ! Lorraines ct this week : NED !! 10 months NED, 22 months of stability overall !!
went to Pres Obamas Rally today. they wouldny let us in , becuase we had FDA ! Approve T DM-1 Now shirts on. asked if we were for the Pres. we said our organization is neither for or against, we are for reforming This FDA. they nicely said , sorry, only the Pres's message gets out today. we had agood time giving out t dm-s1 flyers, info on FDA politics , getting our pic taken. one woman filmed us for a" documentary ". we'll see. you stage iv 'er s who can , got to demonstrate, its exhilirating ! check out the Globe video on http://stageivsurvivor.webs.com

[chrisy]

Phil, great news on Lorraine's scans! I don't see my study buddy often, it was a chance meeting. I don't even know her last name or if she is still on study. Shame on me!

But if I do see her, I will ask her to contact you.

[LeahM]

Great video Phil, good for you...good for all my stage IV sisters. I signed the petition and passed it on....