Re: Access to T DM-1
 

Lorraines story should air tomorrow night ( Thurs, ) ch. 5 boston, at 11. bostonchannel.com. Hope it goes national.

Re: Access to T DM-1
 

Hi Phil,
I look forward to reading Lorraine's story. Thank goodness for the internet...this way we don't miss much. I still can't thank you two enough for all the hard work to help spread the word about T-DM1. When you have time keep us updated on Lorraine. You two take care.

Chelee

Re: Access to T DM-1
 

Check outLorraines' story on bostonchannel.com, Search :
" heidke-mccartin". Lorraine was awesome, I'm so proud of her. You can see how well shes doing. Living proof that this FDA Admin. is botching up the approval process. Cant keep pace with the new drugs. And Kelley Tuthill did agreat job helping us feel at ease, and putting the story together. Lets keep up the pressure !

Re: Access to T DM-1
 

Phil,
Excellent job getting your story across. You even managed to get John Kerry to fire off a letter. This whole T-DM1 issue is so infuriating to me. Especially for us stage IV women.

This link below will take you to Lorraine's story for those that want to see it. It's well worth it...great job!

http://www.thebostonchannel.com/health/27150551/detail.html

Here's to Lorraine becoming NED thanks to T-DM1.

Chelee

Re: Access to T DM-1
 

Those of you who live in the DC or NY area, call your local TV, newspapers, ask for the health editors e-mail. Send them the story.

Re: Access to T DM-1
 

Phil,
I don't live in the NY or DC area...but I still like the idea of calling my newspaper. I use to work for them yrs ago. It might be worth it to tell them about your story, along with my own troubles and opinions on this T-DM1 issue. Maybe I can get their attention? It's worth a try. Thanks for your idea.


Chelee

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.

Re: Access to T DM-1
 

Thanks chelee. Anyone contacting media should mention that Gen. is keeping access from NY, Boston, the whole Northeast.
Schoonder, the FDA and Gen. are talking, taking their sweet time, but they are talking. We must keep up the pressure.

Re: Access to T DM-1
 

genentech announced that they are closing the access program as of Sept. 6. Those already in it will be grandfathered in. They didnt say it, but its related to this FDA's fumbling of the development of t dm-1, a life-saving tx. A drug w/ the best stats coming out of Phase II trials , since Herceptin itself, 15 yrs before. This FDA denies approval of t dm-1 last Sept., recommending 3 more yrs of study, and approves Halaven the same month, a drug w/ much, much less impressive stats. I have nothing against halaven, but this FDA is burying its head in paperwork, refusing to see whats on tv. " Living Proof " , scores of women like Lorraine.Making us jump through more hoops, now its their new mantra , " Overall Survival ".
As research gets closer to winning the war on breast cancer , this FDA is losing it. Speak up !!

Re: Access to T DM-1
 

Chrisy has posted detailed information on this thread:

http://her2support.org/vbulletin/showthread.php?t=50864

Re: Access to T DM-1
 

Important addendum. Gen. is adding a large new trial to try to satisfy this FDA 's new focus on " Overall Survival ",( I call it " Slow As Usual "), at 42 sites, comparing t dm-1 to other txs. None of this should have happened, if ever adrug deserved accelerated approval, it was this drug. Starting in 2010, this FDA began slowing down the process, just as this breakthrough drug was ready.
They refused to see what they had already pre-determined they would not see. Interesting that they began the process of revoking Avastins approval at the same time .
They need to be fixed from above. This is President Obamas FDA, and this Congress's FDA. Make sure you let your reps, and the Congressional " HELP" Committee know how you feel about this FDA. Once they know, then they own it. Its theirs. In an election year. 46,00 women and men will die fron breast cancer this year, and this FDA is slower, more contradictory than ever...

Re: Access to T DM-1
 

Latest update on wider T-DM1 access.
http://assertivecancerpatient.com/2011/08/index.html

Re: Access to T DM-1
 

Lorraine got a call from the research clinic in Va. They have started the process of transferring her T DM-1 Access to Dana Farber in Boston ! We are very, very excited !!
Any woman in the Access Program, traveling long distances to get T DM-1, should contact your site , to ask about transferring to a site closer to home. Make sure the site has started the transfer process. The sooner you dont have to travel , the better.
Any woman w/ Her2 illness that has progressed on taxanes, and tyk/ xel, ( or intolerable s/e w/ tyk./ xel ) can still enroll in Access by Sept 6th. After that a new trial ( Theresa) will be starting, but the start date is un-clear. And any trial will have more regs thatn Access , like a 30day wash-out vs. 2 weeks.
Contact Genentech Access Solutions w/ any ? about the above info.

Re: Access to T DM-1
 

WOW, Phil! I am jumping for joy right along with you and Lorraine. Thanks for letting us know that your long and intrepid work is paying off.

I am also so happy that the drug has done such good for your dear wife.

Re: Access to T DM-1
 

Please support our petition to Dr. Sebelius, asking her to investigate this FDA's denial of Herceptin T DM-1 to Stage IV Survivors. She is this FDAs boss. Go to the link below, study up on the issue, send the word out !
http//signon.org/sign/fda-blocks-life-saving?source=c.url&r-by=60340

Re: Access to T DM-1
 

Phil
Link didn't work for me.

Re: Access to T DM-1
 

The link is missing a colon. It should be:

http://signon.org/sign/fda-blocks-li...url&r-by=60340

rl

Re: Access to T DM-1
 

Newest information posted by Brenda on the Her2 Board:

UPDATE as of today, 9/16/2011, from Genentech:

Genentech would like to provide an update on the protocol amendment to the T-DM1 patient access study (called T-PAS or TDM4884g) that may allow some patients enrolled in the study to receive T-DM1 closer to their homes. We submitted the proposed amendment to the FDA on August 8, 2011, and have received no questions or concerns to date that would require re-evaluation or revision. As a result, we are proceeding with this amendment. All of the study sites involved have been informed, and the next step is for each site to approve and implement it within their own institutions.

The T-PAS protocol amendment provides T-PAS patients the option to enroll into another, ongoing Genentech/Roche study (called the “extension study” or TDM4529g), which, in essence, doubles the number of sites and locations where T-PAS patients can receive T-DM1.. This option is only available to patients currently enrolled in T-PAS. Transferring to one of the extension study sites is optional and available to patients who have completed at least six cycles (18 weeks) of treatment, are determined stable by their doctor (i.e., not progressing and tolerating T-DM1 without major side effects) and meet other required criteria for the TDM4529g study. Current T-PAS patients interested in receiving T-DM1 at a site closer to home should contact the T-PAS study coordinator at their current site. The study coordinator can help determine if one of the extension study sites is closer and begin the transfer process to the new site. Since the amendment requires IRB approval at each of the original T-PAS and extension study sites, some sites may be able to accommodate the transfer of T-PAS patients more quickly than others.

People not enrolled in T-PAS but still interested in T-DM1 should talk to their doctor about their eligibility for the other T-DM1 studies currently enrolling patients.

__________________
Brenda

Re: Access to T DM-1
 

Hi Phil,

I find this site hard to use.....looks like maybe you added this to the existing TDM thread.....I had a hard time finding it, and tried post it myself. It still seems hard to locate and it seems that this site should have about everyone signing if they know about it!

Re: Access to T DM-1
 

Thanks for your efforts Phil. I signed the petition and sent the link to a few other people and asked them to consider signing it too. Even if your efforts are not successful I appreciate the effort you put into this project. You did it for your wife. You also did it for everyone else. That is great !!
By the way, Annmask it is not absolutely neccessary to share alot of details if doing so proves to be difficult or if you don't wish to share some details with everyone. Many of us don't share alot of details. You could do what I did (see below) or post the information you wish to share with us somewhere else and post a link to it in your account. Participation is what is important around here. You did just fine with your post in the other thread.
Take care everyone.