What can we do about the delay of TDM-1
 

Hi Everyone,
I spoke to my oncologist and obviously he is not in a position to get this decision reversed. He is quite upset with the decision because metastatic HER2 patients who have been waiting for the drug are going to die. In fact, there were a number of patients who were scheduled to receive it next week through the expanded access program that will be denied that opportunity.

The reason for the denial is ludicrous. Why would a HER2 cancer patient choose to take awful chemo treatments when more effective target therapies are available? Although the members of the FDA have medical backgrounds, they are not necessarily oncologists, and presumably do not understand the ramifications of the decision they made considering the track record of TDM-1. Obviously, they do not realize the number of patients who will die as a result of their decision.

As many of you know, I was on a phase 1 trial of TDM-1 for two years and it was a miracle drug for me. This drug did not stop working, but I developed lung inflammation. That does still not mean I couldn't try it again in the future.

I am not writing on behalf of myself. It pains me to know that many of you are being denied access to this treatment.

Apparently this decision can be reversed if many of us write and voice our opinions and experiences. The FDA needs to understand why this drug needs to be approved ASAP. They need to know about the number of patients who will lose their lives if they do not reverse this decision. They need to understand their responsibility for these patients.

Unfortunately, I do not have experience being an advocate and do not even know how to get this message out so that the essential people read it. For example, President Obama's 60, 000 letters he receives each day are screened by readers that decide which ten letters he will read on that day. I am also not sure to whom we should send our letters. My oncologist will hopefully let me know if the advocates at the Dana Farber have any ideas.

Please post any suggestions or ideas you may have about this critical situation. Remember, we may be able to make an impact if many of us write.

Thanks for reading and thinking about this issue.

Kind regards,
Barbara Holz

Re: What can we do about the delay of TDM-1
 

Well, Health Care Reform has been a hot topic. I'm sure our e-mails to the White House will get some kind of attention. President Obama's Mother died of a gynecological cancer and their experience with her insurance company was a traumatic one.

Let's get on with it!

www.WhiteHouse.gov

Re: What can we do about the delay of TDM-1
 

I do not believe Obama cares in the least about this decision. This is the start of what Obamacare is all about.

I get disgusted every time I hear him say how hard it was for him to watch his mother argue with insurance companies. I say, Where was he? He was a grown man with a law degree and the one who should have been arguing and then maybe he would understand our plight. I took care of these issues for my mother and my sister when they were ill. This is what family does when they truly care. I think he is a phony.

Re: What can we do about the delay of TDM-1
 

Maybe finding out who the "movers and shakers" at the FDA are and writing to them is a good idea. I think every president has a staff that decides which pieces of mail he sees and what he doesn't.

Re: What can we do about the delay of TDM-1
 

Barbara,
I would love to do something about this T-DM1 nightmare. Sign me up...lets do whatever it takes to be heard. Waiting till 2012 is unacceptable! There are so many women that were depending on this drug...myself included. We need to find a way to get the ball rolling--so lets all put our heads together and be as pro-active as possible.

Nancy...AMEN to everything you said...I couldn't of said it better myself! I'm not sure who we need to direct our letters too...but I do not believe for one minute it's the White House. Now Elaine might be on to something? The FDA might be one good place to start. Lets figure this out and get going on it...T-DM1 has already proven to be a life saver so we need to make sure it's available to all that need it asap. Any other ideas on who we write too please jump in here. (Thanks Barbara for bringing this issue back up to the top.)

Chelee

Re: What can we do about the delay of TDM-1
 

In honor of Joe's memory and work, please let's not let this discussion get into political views for or against Obama etc. Let's just focus on the best ways to help accomplish our goal of getting tdm1 to people who need it. I'm going to send an email to the white house link right now and I'll also send letters to others if any of you come up with names/ addresses within the FDA or other influentials. I don't have the advocacy or research expertise but I can write letters.

Re: What can we do about the delay of TDM-1
 

If Roche files for T-DM1 approval by mid-2012 using Emilia's trial results, then earliest approval for this drug would be onset of 2013.

How about Congressional FDA Oversight Committee for those letters?

FDA refused to look at "any" of T-DM1's trial results because Roche failed to include "all possible" mbc therapies in this trial.
Since T-DM1 a "targeted" therapy has shown to be an effective treatment against HER2+ cancers, extending this trial, looking for candidates that failed those other "much less effective", thus "much less prescribed" treatment options, would've been a "waste of time".
However the FDA, overly risk averse, opted to use this omission, one that really had no bearing on trial outcome of HER2+ candidates, to issue a Refusal To File (RTF) letter. This RTF will delay approval of this very promising drug by at least two years.

Re: What can we do about the delay of TDM-1
 

Thank you to all who have responded. I agree with Pam that in Joe's honor as well as considering the purpose of this website that we should not discuss politics. My purpose for starting this thread is to try to get this decision reversed. I will also write a letter, but I was hoping for ideas about how we can get our letters noticed. I also hope to be considerate about not putting down the FDA. However, I just do not understand how they could have rejected T-DM1.
Hopefully, we can change this decision.
Barbara H.

Re: What can we do about the delay of TDM-1
 

Schoonder's reply is absolutely correct. FDA's refusal was based on the technicality that she describes. Their decision is shortening lives and the quality of the lives of HER2 patients that need it.
Barbara H.

Re: What can we do about the delay of TDM-1
 

I agree, we need to do all we can...too many of us cannot wait until 2012 or 2013 to get this drug. I was ahead of my time for the Herceptin in the adjuvant setting, it was only for stage IV when I was diagnosed. Now, I am stage IV, running out of options, and still unable to get the TDM-1... Does the FDA really think it matters when we have nothing else to try?
If they were in our shoes.............

Re: What can we do about the delay of TDM-1
 

The hopefully 'fatal flaw' in their written decision was the sentence "regardless of HER2 status" ~ 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. It's sounding like a "one size fits all" mindset that is so scary in the bigger picture.

Chrisy knows the woman at Genentech that Joe was very close to... perhaps she can connect us with lobbying folks who know the inner workings of this insane bureaucracy and we can offer our powerful, survivor/patient voice to a coordinated push for the FDA to reconsider their flawed thinking.

As well, if anyone has meaningful connections to Komen, they are the most powerful lobbying group for breast cancer and they are currently applying a full court press in coordination with Genentech to the FDA about Avastin... I am guessing if we hit them with our outrage about this, they would be very interested in helping, if they aren't already in the early stages of it.

Anyone here close to Komen? Or does anyone have an in to Nancy Brinker?

Re: What can we do about the delay of TDM-1
 

Yes. We need to do something that will help all her2 positive people and honor Joe, but still not be too political.
Sorry I mentioned the White House, but I have personal experience with important requests not getting through to the president in a timely manner. I don't think it is President Obama's fault. He is a very busy person and can't take care of every e-mail request personally. He probably gets hundreds every day. His staff may be in a position to decide what he sees and what he doesn't.
I will go to the FDA website to see if I can find out where we can send something to.

Re: What can we do about the delay of TDM-1
 

Re: What can we do about the delay of TDM-1
 

Elizabeth Thompson, Senior Vice President of Medical and Scientific Affairs for Susan G. Komen for the Cure.

5005 LBJ Freeway, Suite 250
Dallas, TX 75244
1-877 GO KOMEN

She is the one quoted about Komen's reaction to the FDA/Avastin situation.

Perhaps we can write her a letter outlining our concerns and see what their position is... see if there is any help they can offer.

I don't have time right now to start a letter, but I can certainly contribute to it.

Re: What can we do about the delay of TDM-1
 

Brenda,
I like your ideas on identifying larger entities/avenues to force the message through.
Another powerful avenue might be news organizations. We saw how media picked up on Herceptin years ago. Regardless of political spectrum, health care issues are hot now in terms of getting viewership or readers. Getting a few TDM1 success story patients in front of cameras..maybe picketing in front of FDA headquarters with a media notification could be powerful. I see some of that with Avastin now.

Regarding google searching, I think having forum topics searchable enhances information access. If concerned over privacy, maybe it means being more discreet with names and e-mails in profiles.

Re: What can we do about the delay of TDM-1
 

Good idea Brenda. I just did a search for "writing to the FDA". Here is what I found so far. I am still checking and might find more later.
http://www.fda.gov/AboutFDA/ContactFDA/default.htm
Please see the left side bar, right side bar, middle employee directory, FDA centers and offices and other information you might be interested in searching.
Even if the TDM1 decision is a done deal we may wish to comment on it as consumers of health care. It might be good for the FDA to hear from consumers once in awhile since FDA decisions may affect our health care. I do not think this is political. The FDA is an agency that is supposed to advocate for us as consumers by checking the safety of the products we use and the medicines we take.

Re: What can we do about the delay of TDM-1
 

I like your contacting the media idea Rich. We have to pick a good one if we want to do that though. Some of us may not want to be in the spotlight. I am one of those. I am better at behind the scenes work. What about writing to some oncology organizations? Is that a good idea? Going back and reviewing how Herceptin and Tykerb got approved might help us get some ideas too.

Re: What can we do about the delay of TDM-1
 

I like all the ideas. I think we should at least start a petition type thread and we can all sign it and possibly print it and send to whomever we think would help assist us. I would be glad to do whatever I can.
I also think we Rich's idea of media is excellent. With all the c--- I see on the morning shows, our issue would surely enlighten someone who needs this drug too.
My daughter lives in D.C. and I can always go visit her and try to do something there.
Let's get this thing rolling!!!!

Re: What can we do about the delay of TDM-1
 

All the ideas are good. See what we can do when we put our heads together !!
One more idea. We could team up with another organization like Susan Komen or others and do something.
By the way, "Stand Up To Cancer" will be airing on most of the T. V. channels on September 10th. That is a program about raising money and awareness for cancer research. I think they have a website. Should we look around there for ideas?

Re: What can we do about the delay of TDM-1
 

What might have lead Genentech astray.

Was omission of certain non-HER2+ therapies in their T-DM1 trial design a glaring oversight by Genentech that compelled FDA’s RTF response, or was this a misunderstanding by Genentech attributable to lack of specificity by FDA during preceding trial discussions?

Did FDA’s acceptance of trial requirements that did end up receiving Accelerated Drug Approval mislead Genentech in T-DM1's trial construct?
Case in point a recent accelerated approval ruling re: Tykerb where, according to FDA Tykerb WAS NOT compared to Trastuzumab-containing chemo regimen for treatment of MBC. This compare could be done later, why not allow Genentech to correct their shortcoming in the "compassionate" trial setting?
FDA approves TykerbR for use with letrozole to treat certain postmenopausal women with hormone receptor positive metastatic breast cancer


On January 29, 2010, the U.S. Food and Drug Administration granted accelerated approval to lapatinib tablets (Tykerb®, GlaxoSmithKline) for use in combination with letrozole (Femara®, Novartis Pharmaceuticals Corp.) for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor and for whom hormonal therapy is indicated. Lapatinib, in combination with an aromatase inhibitor, has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. The approval was based on a clinically meaningful increase in progression-free survival (PFS) observed in a single trial (EGF30008). As a condition of accelerated approval, subsequent randomized trials are required to verify and describe the clinical benefit of lapatinib in patients with metastatic breast cancer who have received prior treatment with trastuzumab.

EGF30008 was multinational, randomized, placebo-controlled trial of lapatinib plus letrozole versus placebo plus letrozole in patients with hormone receptor-positive metastatic breast cancer who had not received prior therapy for metastatic disease. Patients were randomly assigned to receive lapatinib (1,500 mg once daily) plus letrozole (2.5 mg once daily) or to placebo plus letrozole (2.5 mg once daily). There were 219 patients (17%) who were HER2-positive, 952 (74%) patients who were HER2-negative, and 115 (9%) patients did not have their HER2-receptor status confirmed.

Accelerated approval was based on the results from the group of postmenopausal women with metastatic breast cancer that overexpressed the HER2 receptor. The primary efficacy endpoint was PFS, defined as the time interval between randomization date and the date of either first documented disease progression or death due to any cause. The lapatinib plus letrozole combination had a median PFS of 35.4 weeks compared to 13.0 weeks for the placebo plus letrozole arm (HR = 0.71, p = 0.019). The overall survival data are not mature at this time.

Safety data was evaluated in 1278 postmenopausal women with hormone receptor-positive metastatic breast cancer. The safety profile of lapatinib in this trial population was consistent with previous safety data. The most common adverse reactions (=10%) in the lapatinib plus letrozole arm were diarrhea, rash, nausea, and fatigue. Elevated liver enzymes and bilirubin were reported in 53% and 22% of the patients receiving lapatinib, respectively. Among 654 patients who received the lapatinib plus letrozole treatment, 26 patients experienced Grade 1 or 2, and 6 patients experienced Grade 3 or 4 decreases in left ventricular ejection fraction.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available on the FDA website.

http://www.asco.org/ASCOv2/Practice+&+Guidelines/Practice+Management+&+Reimbursement/FDA+Drug+Alerts/FDA+approves+TykerbR+for+use+with+letrozole+to+tre at+certain+postmenopausal+women+with+hormone+recep tor+positive+metastatic+breast+cancer
Roche surely isn't shirking their responsibility in completing evaluating T-DM1, presently company is conducting two large, international MBC phase III trials. The issue is that, what appears to be a minor technicality, an inconsistent ruling by FDA, is keeping this drug for at least two years out of hands of critically sick people, of which a good many no longer have viable options for efficacious treatment on hand.

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

I agree Brenda.

Re: What can we do about the delay of TDM-1
 

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?

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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

Re: What can we do about the delay of TDM-1
 

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

Re: What can we do about the delay of TDM-1
 

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

Re: What can we do about the delay of TDM-1
 

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

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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...)

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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/

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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?

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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.

Re: What can we do about the delay of TDM-1
 

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/