What can we do about the delay of TDM-1 - Page 2

ElaineM · 09-05-2010, 04:14 PM

Here is a number to see if the T DM1 expanded access
program has been affected by the FDA's decision.
1-888-662-6728
This is the TDM1 Expanded Access Trials Support number.
We might also like to check genentechclinicaltrials@druginfo.com
or the genentech website for updated information.
clinicaltrials.gov
Trial number NCT00558 103 Glaxco Smithkline.
Good point Darlene. Some of our ladies who see Dr. Salmon might want to ask him about it and if Lily can give us some advice that would be good too.

Barbara H. · 09-05-2010, 05:26 PM

If we can be effective, The FDA does procedures to reverse their decision.
Barbara H.

evlin75 · 09-05-2010, 10:55 PM

Hi folks, my daughter was also watching the trials of TDM1 as she is her2+ and does not want to do all the hard chemos before getting a medication targeted to her diagnoses.
I would try GMA as they seem to be more open to publicising problems cancer patients have with health coverage. She is on Xeloda and Tykerb.....and regular Herceptin but her markers are starting to move up. She does not want to take Taxol and is considering a clinical trial that has TDM1 with GDC 0941.
Good Morning America aired her story when she was having trouble with her company giving her disability and I feel they would be sympathetic to this difficult situation, explore it and get some attention to the problem.
My daughter volunteers with Komen and yes they are trying to help.
And yes, I was sorry to hear about Joe.
Courage!
Ev

DiDi70 · 10-13-2010, 12:22 PM

How about a directed campaign of letter-writing to everyone's local newspaper with an email sent out in advance to all media outlets, particularly those in Washington? This would create buzz. Also, would there be any benefit in contacting local offices of Members of Congress, to ask their opinion on who we can contact in the hope of making an impact?

I suggest also, trying to contact celebreties, who get a ton of press and who have no qualms, usually, about speaking out. Maura Tierney, who is an actress and who starred for years on ER, has a new series out now and she is all over the media, having just battled breast cancer too. A letter to a group of celebreties who have been through what we are going through might gain some momentum - especially when this is cancer awareness month and there's a lot of press-coverage for cancer topics. It couldn't hurt to try, I think.

Is there anything that I can do from Canada to help out?

hutchibk · 09-05-2010, 03:24 PM

Two voices we need to have as support of this are Dennis Slamon and a spokesperson from Genentech. We need to be sure we are approaching the media, the FDA, lobbiest, etc with a very concise and scientifically factual message.

ElaineM · 09-06-2010, 10:11 AM

If you want to contact Susan Desmond-Hellman or
Lily Tartikoff this might help.
http://www.pipl.com. I find this search engine helpful when I want to find people.
If you want to work with ABC's Good Morning America you might want to contact Anchor Robin Roberts. She is a breast cancer survivor,so she might be willing to do a segment on TDM1.

ElaineM · 09-07-2010, 10:24 AM

Thanks Brenda and Chrisy. I am going to start composing a letter this week. Are we also going to start a general petition for everyone to sign? I hope Chrisy or another representative can be our media contact. I applaud your efforts Brenda. I am looking forward to reading your interview in Cure. I signed up for a free subscription, so I get that regularly.
I agree Brenda. It seems silly for researchers and authorities to say targeted drugs are the future of cancer treatment and then try to stop promising targeted therapies from getting to the people who need them makes me wonder what are they really doing or saying? I thought the news about Avastin was bad enough. Slowing down T DM1 on top of that is unacceptable. I hate to make this a gender thing, but does the FDA have something against women with breast cancer? Maybe we should find some men who are Her2 positive to write some letters too. By the way, during my own personal research I found her 2 is not limited to breast cancer. I read It can affect other cancers too, but I have not researched that further, because I am trying to learn all I can about breast cancer and I have limited time.
By the way, if you go to the pipl link I included previously you will find Lilly Tartikoff. I tried it. It works. It should be easy enough to find Dr. Slamon's contact information. Do you think we should contact the editor of Cure Magazine? Do you think Cure could do an article about the FDA activities and/or TDM1?

VirginiaGirl · 09-08-2010, 10:37 AM

As one of those people who were looking to T-DM1 as my next promising treatment option, I too am very disappointed, and scared, that it may well be another 2 years before it's approved. I was initially dx right before (but not in time to get) Herceptin was approved for early stagers.

I was hoping to find support for this issue from Breast Cancer Action, a bc advocacy group. Unfortunately, what I found on their website (bcaction.org) was a letter to the FDA OPPOSING fast-tracking T-DM1 (and their position against approval of Avastin for mbc). Their T-DM1 letter (copied from their website) is below. At least we can write to/email the same person and express a different viewpoint!

"
March 23, 2010
Richard Pazdur, M.D., F.A.C.P.
Director
Office of Oncology Drug Products
U.S. Food and Drug Administration
richard.pazdur@fda.hhs.gov

RE: Opposition to TDM-1 Fast Track Application

Dear Dr. Pazdur:

As you are no doubt aware, Genentech intends to seek fast track approval of TDM-1 based on the results of a single-armed, Phase II trial.

It is our understanding from the sponsor that the FDA was asked two years ago about what would be required for fast track approval of TDM-1, and that the agency took the position then that a randomized trial would be necessary.

Despite this clear direction from the agency, the company has completed -- and will seek FDA approval based on the results of – one single-armed trial, TDM4374g.

Breast Cancer Action believes, as the FDA does, that only sufficiently large, randomized trials will give us the information we need about drug efficacy and safety. We urge you, in the strongest possible terms, to require the sponsor to submit Phase III data before you consider approval of TDM-1 for breast cancer.

We understand that there is an important unmet medical need for people with advanced breast cancer whose treatment options have run out. We desperately hope that TDM-1 proves to be a beneficial option for these people. But we oppose sacrificing drug approval standards on the altar of hasty access.

As you know, the FDA used to require the results from two Phase III trials before considering approval of a drug for the market. More recently, a single randomized trial has been found by the agency to be sufficient in some cases. We think this weakens standards for drug approval. Please do not weaken them further by allowing marketing based on a small, single-armed Phase II trial.

We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial.

The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market,

Sincerely,

Barbara A. Brenner
Executive Director

Note: As a matter of policy, in order to avoid the fact or appearance of a conflict of interest, Breast Cancer Action does not accept funding from Genentech or from any other pharmaceutical or biotech company."

ElaineM · 09-08-2010, 03:34 PM

I called Genetech to try to get information today. The person I talked to told me they have not canceled the extended access program for T DM1 yet. They still have 9 sites open and are still planning to set up more. He also told me the phase 3 Emila study is still in operation. Other her2 studies involving Herceptin and/orTDM 1 such as the TDM4450g, MARIANNE, and the CLEOPATRA are still active.
I asked for more information and was directed to someone else. That person directed me to the Genetech website (www.gene.com) and suggested I look in the media section regularly for updates. I followed her directions.
The latest press release can be found at
http://www.gene.com/gene/news/press-...etail&id=12947
I think it is a good idea to check for press releases regularly.
http://www.gene.com/gene/news/index....btn=Web+Search

Patb · 09-08-2010, 04:05 PM

Thank all of you for your work on this matter. I know
little about it but am willing to help send e-mails, etc.
because my dear friend stage IV was declared all
tumors gone today at the Indiannapolis trials. She
is elated. They will contine the treatment for awhile.
Her lungs and nodes were clear.
patb

ElaineM · 09-13-2010, 09:40 AM

Can something be done on You Tube? Any volunteers?
I can put a link to any petition we may want to start on my website.

Emelie B · 09-13-2010, 09:55 AM

Did we get a petition drafted yet? Elaine-that is a great idea. How can we get this done?
Let me know what I can do and I will be glad to help.

Chelee · 09-17-2010, 03:22 PM

Elaine...I never thought of You Tube...another good avenue to use. I really don't want any of us here to drop the ball on this one. We need to strike asap. My onc had not even heard about this, but did say we should be pro-active and jump on it. I told her that's what were doing. We want to get our voices heard.

So as one big part of this are we going to draft a petition and have everyone sign it? I know we could get alot of signatures for this with no problems. So many good idea's here...so what should we all be doing now that will have the most affect?

There are so many of us that don't have that option of waiting till 2012 or worse yet 2013. Any other great idea's pls throw them out here. If Joe was here he would be all over this...so lets make him proud of us. That's a big part of why he and Christine built this board. So lets get it done...I know we can. This is too important not to give it our best shot.

Chelee

ElaineM · 09-18-2010, 02:18 PM

As promised here is the link to the petition site for anyone who wants to start a petition about the recent FDA decision about the T DM1. I am not the one to start a petition, because I prefer not to disclose my health problems to some family members, friends, co workers and associates. I have only shared my health problems with a small group of people who will keep it confidential. This has worked well for me for almost 12 years.
http://www.thepetitionsite.com/create.html
You Tube, interviews, news articles, or media appearances are better left to those who don't mind going public about their health problems. I prefer behind the scenes kind of activities like research etc.
I still want everyone who is eligible for T DM1 to receive it in a timely manner. It is one of my greatest wishes, because it is such a promising drug.

ElaineM · 09-05-2010, 03:51 PM

I agree Brenda.

Darlene Denise · 09-05-2010, 04:11 PM

Anyone have an in with Lilly Tartikoff? She is friends with Dr Slamon, helped him raise money with Revlon for Herceptin and has partnered with Catie Coruic (there is our news connection) on cancer issues. She played a large role in bringing Herceptin to us with all of the money and drug company issues. I understand she is still very involved in cancer projects. I think she could be very powerful if we could get to her. What about some of our ladies who see Dr Slamon. Perhaps he could get us on track with something?

hutchibk · 09-05-2010, 04:34 PM

I spoke to the Genentech clinical trial support line on Thur and Fri (at 4 pm cst on Friday) and they say they have heard no word at all that the EAP will be curtailed or discontinued, and they are still pre-screening folks for the current locations. One other thing I seem to remember that I learned is that they are only planning on accruing 200 total across the country for the EAP. I can't for the life of me remember who told me that, but it was on Thur (since I talked to Genentech support and to an EAP location coordinator... can't remember who said it). The last person I spoke to at Genentech support told me she had 8 new locations that were pending for EAP, awaiting full approval...

I wouldn't be at all surprised to hear word soon that the EAP might be suspended. I certainly wouldn't blame them if they decide to suspend for now and re-open it around the time in 2012 that they plan to submit the BLA again... I believe it is designed as a 'bridge' for mets patients to help carry them over to full market approval, and now that that has been set back, it would be an expensive proposition to continue accruing the program for 2-3 years as opposed to 6-8 months that I think they believed would be their accelerated timeline to market.

Just one girls opinion.

Darlene Denise · 09-05-2010, 04:55 PM

Lilly Tartikoff lives in Beverly Hills. Could our Dear Flori get us any scoop about how to reach her?

Rich66 · 09-05-2010, 06:55 PM

As far as success stories, I notice Chrisy had liver mets brought to NED via TDM1. Whatcha say Chrisy..ready for your closeup?

Rich66 · 09-06-2010, 12:28 AM

Hmmm...those seem like ready made connections. Could get Chrisy as success story and Ev's daughter and others for the wannabees. Slamon and or other docs to anchor the medical side. Wasn't Dr. Sledge going to participate on this site? Maybe he would be another medical voice to pursue.