What's the latest on TDM1?

['lizbeth]

I am still unclear why it wasn't fast tracked.

Has anyone made any progress on voicing their dismay on the FDA decision?

[GracePang]

I have the same question. Why would they hold it for 2 years?

I was expecting it to be available by the end of this year. I don't have access to Tdm1 trials, since I am from a city in Canada that don't have this trials.

Hope they can change their decision and have this drug available for us ladies who need it.

[chrisy]

To address the questions above from 'lizbeth and grace:
The FDA refused to file the fast track application on the grounds that the study did not meet the standard of filling an "unmet need" because it was a single-arm study (no control group) and the study population had not exhausted all available treatment options, regardless of Her2 status. So the FDA would not file the request for accelerated approval.

Obviously, we on this forum see it differently.

So the additional 2 year "wait" is the normal timing of the Phase III registrational trial EMELIA.

Several individuals, myself included, have been working on responses, making contacts etc but given that the group itself is somewhat in a state of transition following Joe's passing we have not yet responded formally as a group.

I have been in contact with Danielle (Christine and Joe's daughter) about having a page on this site on which we can discuss this topic, provide direction and support to those who wish to send letters etc. I've been collecting and researching content for it and this will be in the works. I hope we can also create a position paper and formal letters in Her2support's name - but have not yet cleared this with Christine.

In the meantime, there is much information on the thread "what can we do about the delay of TDM1" (see link below), including guidance on who at the FDA to contact as well as "how to contact your congressional representatives". Maybe especially any newbies who may have blank todo lists on Nov. 3.

I have been told that that is the most impactful way to be heard - lots of letters.

IF YOU HAVE THE ability (and there is a lot of info to use in the thread below), to write your own letter please do so now. While it is important to be factually correct, your input as a her2+ patient waiting for access is important in its own right. As a Her2+ survivor you have every right to make your voice heard so feel free to speak up - firmly but appropriately. You can add your voice to any group efforts later, too!

You don't have to write a new War and Peace - or wait for anyone else.

There is some more current discussion on this thread:

http://her2support.org/vbulletin/sho...ht=tdm1&page=4

[schoonder]

Early stages both preclinical and clinical of Genentech’s effort to develop T-DM1 as a new treatment for 3-line Her2+ metastatic breast cancer occurred when Susan Desmond-Hellman, now chancellor at UCSF, was still in charge of product development. During that time the company designed and conducted a couple clinical phase I trials to establish an optimum dosing regimen and followed this up with two phase II trials; the second of which required participants to have failed or not respond to Herceptin and Tykerb/Xeloda medication which are regarded as leading therapeutics for this indication.
Susan chose to leave Genentech when Roche took over control of company. I don’t know if change in leadership of product development at that time in any way impacted conduct, participation, completion of that 2nd phase II trial.
It might however be beneficial to touch base with Susan and get her views as to what she thinks went wrong with Roche’s filing and possibly get some inputs from her as to best possible way to rectify this situation.

[ElaineM]

Thanks everyone. Thanks Chrisy. We have to keep this going for all of us no matter what our status is.
In addition to everything else we should keep talking to our docs about T DM1. If we keep asking for T DM1 or about T DM1 that will keep it on their minds too. Perhaps our docs with all their contacts can keep the discussion going in their circles and by doing so spread the word about the concerns of their patients to people who are able to take some kind of positive action to get it approved sooner rather than later.

[chrisy]

Good point, Schoonder - I'll bet Ms. Desmond-Hellman would have some interesting perspectives. Someday maybe I'll get the opportunity to talk to her, but it's not at the top of my list as I feel I've gotten a good amount of input already.

Personally, my homework assignment for myself this weekend is this:

1. Haul out the reams of data I've collected (much of which was posted on the other thread).

2. Heed the advice I've received about the best possible way for ME to impact this which is to write, and encourage others to write to the FDA and congresspeople and make my voice heard.

The FDA is first for me; Gene/Roche is in ongoing talks with the FDA to get clear direction on what it will take to get TDM1 approved. So now is a good time for them to hear from ME.

3. MY main points will include my Her2/TDM1 resume, the significance of using Her2 directed therapies vs. "all available options", the need for Her2 target options, urgency of the unmet need as it relates to Stage IV folks, and the need for the regulatory/approval process be in synch with the direction and velocity of the science. The purpose of the FDA is to protect patients from harmful or ineffective treatment. The impact of the current FDA approach is achieving the opposite - preventing access to effective and low toxicity medicine. Somehow all in one letter.

I'm continuing, and will continue to collect data, find alliances and look for ways to help organize and support people. But I do believe I, and we, have a considerable number of cogent arguments and a unique perspective as Her2+ patients.

I know, from participating in the other thread, http://her2support.org/vbulletin/sho...ay+tdm1&page=2that there are a good number of you who are well armed and articulate enough to do the same. In fact, I'm plagiarizing from some of you!

So my homework is to get off my butt and write the letters. It's a start. I'll show you mine when it's done...and I'd like to see yours too!

FDA Contacts and how to contact congress below:


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 begin_of_the_skype_highlighting 301-796-5040 end_of_the_skype_highlighting
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/

[Joan M]

'lizbeth,

Here's a news report on the FDA's denial.

www.verusmed.com/articles/view/64970/

Joan

[ElaineM]

Here is a list of T DM1 clinical trials that are active or not yet recruiting.
http://www.clinicaltrials.gov/ct2/re...linical+trials

['lizbeth]

Thank you all for helping me to understand the situation. I want to make a difference, so I will be sifting through the information and attempting to create some letters.

Once I've put things together I'd better post a preview so others can help me be factual and, since chemo, gramatically correct.

Thanks all.

[ElaineM]

In addition to what I am doing personally I am willing to put a link to a "in support of T DM1" petition we start on my website and on the personal e-mail account I use for medically related e-mail.
I did this to promote an event sponsored by another organization I belong to and found this to be a good way to promote the event without cost. Every e-mail I sent advertised the event for free. Every time someone visited the website I have for that organization they saw the event advertised for free.

[GracePang]

Chrisy, your own story shows that TDM1 works, which is a powerful message. I am from Canada and don't know if my letters would count. I will read yours and sign any petition you and Elaine would start.

[ElaineM]

This information might be helpful in our quest to get
T DM1 approved.
CANCER DRUG DEVELOPMENT AND APPROVAL
By, Ginny Mason, RN, BSN
Executive Director, ibcRF
The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.
The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.
In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov
A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.
To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.
http://www.cancer.duke.edu/docs/Canc...01009-Fall.pdf


CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.

CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.

CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.

[schoonder]

http://www.genengnews.com/keywordsan...print/3/20947/

[Sandra in GA]

Thank you Schoonder for posting this~Sandra

[ElaineM]

I wanted to know more about DM1 and found this interesting article about it.
http://www.scrippsnews.com/content/n...-shows-promise
I am always curious about how things work. Smile.

[schoolteacher]

Last week when I went to the oncologists, I had to sign another set of papers to be in the TMD1 trial.

The study has doubled the participants from 400 and something to 900 hundred and something.

I wondered if this would slow the trial down? I sure hope not.

Amelia

[ElaineM]

Congratulations on getting in Amelia. It doesn't matter how much paper work there is. The main thing is that you are headed in the T DM1 direction. I hope it goes well.

['lizbeth]

Schoolteacher,

I don't know if it will slow things down, but I did have discussions about reported trials with my medical team and they would say "Well, that's just a small study". So in my mind the more the merrier.

[Debbie L.]

I'm at NBCCs Project LEAD Clinical Trials course in Virginia. Yesterday we heard that the EAP for TDM-1 has been extended (is not closed), although no word on for how long or what changed. I can't find any "news" via google about it. Anyone have the scoop?

Debbie Laxague

[ElaineM]

Maybe you can find out here.
T DM1 Expanded Access Trials Information Support Line
1-888-662-6728
I hope it has been extended for everyone's sake.
Otherwise I put a link to a list of T DM1 trials earlier in this thread. If the EAP has been cancelled you can try to get into a trial.
Good luck. Let us know what you find out.