What can we do about the delay of TDM-1

[hutchibk]

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]

I agree Brenda.

[Darlene Denise]

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?

[ElaineM]

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.

[hutchibk]

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]

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

[Barbara H.]

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

[Rich66]

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

[evlin75]

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

[Rich66]

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.

[schoonder]

T-DM1 was developed during the days that Susan Desmond-Hellman presided over product development at Genentech, presently she's chancellor at UCSF. Her support would strengthen this case from the technical perspective. Chrisy could possibly get to see her, win her over on this subject matter when at UCSF.

[ElaineM]

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.

[hutchibk]

Sounds like Chrisy is our linch-pin to a few good ideas...

And just a recap of some of the ideas:

"get ducks in a row"
1. reach out to Genentech
2. reach out to Dr. Slamon (Dr. Sledge or Dr. Julie Gralow in Seattle at SCCA, she is running a TDM1 study and could advise us.)
3. reach out to Susan Desmond-Hellman
4. reach out to Komen, (Dr. Winer is on Board of Science Advisors)


"media outreach"
1. reach out to GMA/national TV talk shows
2. reach out to local TV in cities where survivors live
3. reach out to cable news channels
4. reach out to women's magazines

"Lobbying/advocacy"
1. reach out to KOMEN for lobbying and support to cut through bureaucratic walls.
2. reach out to our local Senators and Congressfolks.
3. reach out to Lily Tartikoff.


(I am scheduled to be the subject of a monthly spotlight on breast cancer survivors on our local ABC affiliate in either Oct or Nov, will highlight the TDM-1 problem, as well as a follow-up article on me in CURE Magazine before SABCS, in which Kathy LaTour also knows I will highlight the TDM-1 refusal...)

[ElaineM]

Thanks for helping us stay organized Brenda. Thanks for highlighting TDM1 in your upcoming interviews.
Keeping T DM1 in the spotlight will help. If each one of us "talks it up" to our medically related contacts that will help too. Let's keep T DM1 in the spotlight whatever way we can.
"The squeaky wheel gets the oil."
Smile.

[chrisy]

Brenda - well organized indeed. I've spent all morning researching the discussion on other websites and sending emails.

Your earlier post on this thread, about needing to have clear, concise and scientifically factual info is critical. Talking points if you will.

I also found some good discussions on other boards so far, including this one:

http://www.inspire.com/groups/advanc...ecent-setback/

[Midwest Alice]

10/16/10 Metastatic Breast Cancer Network conference in Indiana
I am 3 hours away and will be going.

We should be able to launch a media campain from this conference.

I can write letters to the editor about the people I meet there and the effect the FDA rulling will have on their life. I will try the Wallstreet journal and the Indy Star.

If we could do video interviews of women who would have started theatment we could put it on youtub. I don't know how to do that. I can run a vido camera and maybe interview willing women at the conference.

My daughter is a marketing person. Maybe I can get her to go with

The November elections are not far off. Go to rallys and debates and hang around till the end and meet the people who our running for office. They need to see are faces and feel our hand in theirs. We need them to remember us and our story.

[chrisy]

All of these ideas are great. With Pinktober just around the corner, there should be opportunities to generate conversation. However, that is a month away... When placed in context with the FDA's pending decision on Avastin, it's clear to me that the voices of both metastatic bc patients and Her2+ patients are not being heard.

I suggest, based on some conversations I've had in the past day or so, that if we want to have impact we need to act now, while the issue is "fresh". And continue to keep the volume up after that.

The most immediate impactful action we can take is to individually, as a group, and in concert with others (the outreach to Komen and other groups with interests in common) is to write to the FDA, copy our representatives in Congress - as well as those with aspirations to become our congresspeople and senators.

Who remembers the end of Miracle on 34th street??? Our response needs & deserves the "put it here on my desk" treatment. Since we probably won't be invited, we'll have to put it there ourselves - via email, snail mail, fax. But just as many bags. Again, they need to hear our voice.

I agree with I think Brenda's comment; we must be succinct and factually accurate; but the issue is not only a scientific one, it is a perspective.

Let's hear it - what are the salient points we would need to include in such a letter? If we can design a basic format then we can pass it on and people can send, amend, personalize or whatever...

Here are a few points (NOT succinct, yet!) we might be able to use:

We are Stage IV breast cancer patients. We have benefited from TDM1 or need access to TDM1 because we are running out of options or want options that offer good QOL. Our need is now...not 3 years from now.

We are Her2+ breast cancer patients. Science is moving very fast towards targeted and personalized treatment. Her2 overexpression in BC became a prime therapeutic target, with game changing results.

We are asking the FDA to consider the unique needs of the metastatic breast cancer community, and the Her2 cancer community. (how many people IS that, anyway?)

For people living with metastatic disease, it is important to have options. (what does that mean for you?)

Options that enable us to live more fully and with greater quality of life are a big deal. Phase II studies indicate TDM1 has a low incidence of significant side effects, especially compared to traditional chemo. Although I'm just a single datapoint, I personally have enjoyed great QOL on TDM1

Time is also a big deal - what Stage IV patients need MOST is faster access to therapies that can extend life and improve quality of life. True, we don't want to sacrifice good science on the alter of expedience - but more importantly, we mustn't sacrifice LIVES on the alter of caution. Stage IV patients simply cannot wait.

Emerging science is our best hope and tailoring therapy to the individual's disease is key. Requiring patients to run the gauntlet of "one size fits all" therapies as a precondition to try the "custom made therapy" seems completely the wrong direction.

The approval process needs to keep up with the science.



What have I missed? (I deliberately left out any personal opinions and tried to be rational - after all if I'm trying to influence someone at the FDA I'd rather have the letter actually have a chance of being read!)

If you've already written, or are writing a letter could you share it here?

[hutchibk]

The sentence "regardless of HER2 status" disturbed me the most in the decision... ~ you can't approach efficacy of potential new treatments for HER2 cancer from a "regardless of HER2 status" standpoint... IT IS ALL ABOUT THE HER2 STATUS. That is why they are developing these targeted treatments, because if the other available treatments that "have not been exhausted by the study patient population, regardless of HER2 status" worked for us, then there would be no need for intense research and focus on treating this subgroup. By the time we exhaust those other treatments, it is often the end of our road... with progression to the point that it's potentially too late to try a 'new targeted treatment'....

It's sounding like a reversion back to that "one size fits all" mindset that is so scary in the bigger picture.

[schoonder]

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.

[chrisy]

Well said, Brenda and Schoonder. And on point. I know you won't mind if I plagiarize I think the FDA is applying old rules to a new game, and it just doesn't work.

When we say it to the FDA, cc your congresspeople and your newspapers. I'm working on my letter now. Just the other day, the FDA reversed position on another drug they were about to pull, based on overwhelming response.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993



Commissioner Margaret Hamburg, M.D.
301-847-3531 (fax)
margaret.hamburg@fda.hhs.gov


Deputy Commissioner Joshua Sharfstein
301-796-5040
joshua.sharfstein@fda.hhs.gov


Director Dr. Janet Woodcock
Center for Drug Evaluation and Research
Building WO51
Room 6133
Mail stop HFD-001
301-847-8752 (fax)
janet.woodcock@fda.hhs.gov


Director Richard Pazdur, M.D.
Office of Oncology Drug Products
Building WO22
Room 2212
301-796-9909 (fax)
richard.pazdur@fda.hhs.gov

Contacting congress:
http://www.contactingthecongress.org/




Also of note, check out the attached link to the petition re the FDA pulling Avastin. Could be another path to make our voices heard. Some of the issues are the same and we have many people on this board benefiting from Avastin who potentially could lose this also!
http://www.thepetitionsite.com/3/sto...breast-cancer/