What can we do about the delay of TDM-1 - Page 4

Jean · 09-23-2010, 06:42 AM

Sheila,
I am hoping that your cardo dr. will have a plan to raise your muga. I feel your frustration and I am praying that we will hear a solid strong plan so you can get on to the TDM1....

Sending you love,
Jean

michka · 09-23-2010, 07:19 AM

Oh Sheila! You have been waiting so long. I hope you will have good news coming from your cardiologist and that you will be able to jump in the TDM1 wagon. Waiting to read your next post and thinking of you. Michka

Trish · 09-23-2010, 08:52 PM

Oh Shelia, hoping, hoping, hoping you catch this break.....
Trish

DeenaH · 10-11-2010, 08:52 PM

I just heard about this last night and can't believe the FDA did this!

I'm not sure what is happening now with the letters, media, etc, but I have Dr. Slamon's contact info (or his Nurse Practitioner's) and have a consult with him November 22nd. I know that's really far away, but I can bring it up face to face if nobody gets a hold of him sooner.

His nurse practitioner is Kimberly Podsada. She can be reached at (310) 829-5471 and kpodsada.mednet.ucla.edu. I know it's not direct contact to Dr. Slamon, but she works directly with him.

If I can hand deliver a letter or any info in November when I see him, I can do that too. I am not stage IV, but I am scared to death of a recurrence because I still had alot of cancer after chemo, at time of surgery. Before chemo it showed on the PET/CT as being in my mammory nodes as well as my neck, 7-8 axillary nodes and a 7cm tumor in my breast. At surgery, the tumor did shrink to 3.2, but I still had 18/51 positive nodes and cancer in the fatty tissue between levels 1 and 2. Even though I would show as NED on a PET/CT now, I don't believe I am for one second. Even though I don't qualify for TDM1 now, I might need it in the future. Even if I don't, I want to fight for those who need it NOW!

This is just so frustrating!

Jackie07 · 10-11-2010, 09:21 PM

Not sure what Dr. Slamon can do about it. But perhaps you can print this thread and show our 'outcry' to him?

Chelee · 10-12-2010, 12:58 AM

DeenaH,
I'm still willing to do anything we can about this TDM-1 nightmare. If we are pro-active enough I believe we can make changes & speed this process up. There were so many of you here with great ideas...I thought we were off to a great start.
TDM-1 needs to be available for women with metastatic & earlier stage bc. I was looking forward to at least some more EAP sites..but we now know that's not going to happen either.

The ramifications from denying us access to TDM-1 is serious...it will cost some of us our lives. Why should women have to beat up their bodies first with all these toxic chemo combo's first to make the FDA happy. I'd sure like to get the ball rolling on this some how?

Jackie's idea is a good one. I've talked with Dr. Slamon and he is very geninue...he cares. He might be able to give us the best direction to go in? It's worth a try. I'm also open to Elaine's idea of a petition...and I know of another bc board where there are lots of women upset about this very same thing, & will gladly join in to sign petitions, write letters...or whatever it takes. I'd also like to "steal" Shelia's line that she used to get attention when she was fighting for Tykerb. She said to them, "I am dying to try this drug!" Perfect...gotta love it.

Remember the news on TDM-1 has been shown to work great as a 1st line therapy...this isn't just for metastatic bc...this is to benefit all of us.

Chelee

ElaineM · 10-12-2010, 10:06 AM

Thanks for reviving this subject. I was wondering what if anything we have decided to do about it. If I remember correctly some people were willing to be interviewed. Some people were going to write letters.
Somebody was going to ask Christine for her opinion.
I said I would sign a petition and offered to do research. I included several links to important information during our discussions. I thought October would be perfect timing, because it is breast cancer awareness month.
It seems the subject has been dropped. I don't know why. I wish I knew. Maybe we all got too busy, but this subject is an important one for every one of us, even those of us who are NED, because unfortunately cancer can return at any time, even years later.
I heard expanded access will end October 31st. However, some of the T DM1 clinical trials will continue.
If interested people go to clinicaltrials.gov and do a search for T DM1 they will find available trials. I guess that is the only option until the FDA fully approves T DM1.

Chelee · 10-13-2010, 02:34 AM

Elaine,
Very nicely done...you summed up most of what was all discussed in this thread...pretty good girl.

Like you I would like to know why the interest in this thread has been dropped too? Everyone was so fired up and again with great ideas and wham...it all stopped? I do know some got into the EAP sites so they just might be really busy with all the running around? I know when you join a trial your lucky if you can come up for air. But I sure hope those, and anyone else here will feel like jumping in to do their part...it's to help all of us. We can make a difference. Actually with elections coming up, along with Pink October...this is a perfect time to make ourselves heard.

Elaine makes a very good point...cancer can return at any time and it would be so nice to know we all have TDM-1 avaliable instead of all those toxic chemo's to run through! TDM-1 has been such a life saver literally to so many. I sure hope we can get those that were interested in this to come join us. We need to strike now...the sooner the better.

Chelee

ElaineM · 10-13-2010, 10:53 AM

Thanks for your comments Chelee. I would like to keep this discussion current for those people who reach the point where they need T DM1. Everyone has brought up important points and there were several links that might be helpful to some of our members. Maybe additional information or news about T DM1 can be added from time to time, so that people who need the information can have it in a convenient place.

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?

chrisy · 10-13-2010, 04:54 PM

I wouldn't say that the subject has been dropped...or that interest in the subject has been dropped. What has dropped is visibility and discussion of it on this thread.

What is pending is a strategy and organization to enable us to better make our voices heard, and work to be done in drafting sample letters and hopefully a position paper. I have been actively working on this with a few of the folks who had posted on this thread to get this started. If you would like to participate in this process, send me a pm.

Some have been taking individual steps, writing letters, trying to get interviews etc. I did take a vacation...but shlepped along about 4 pounds of articles, links and paper to draft letters on. (un)fortunately I didn't have access to keyboards or internet, so I had to spend much of my vacation....relaxing. Now I've been working 7 days a week to catch up but I'm not complaining because being able to have a full life is what it's all about.

I've talked, and learned behind the scenes about how to set up strategies to make our voices heard and researched where we can find allies. TDM1 is a hot issue; and each news report (such as several this week from the Milan meeting) is another opportunity to add our voices to the discussion.

Creating a sustained effective response is new territory for us as a group - we are primarily a support group, not an advocacy group. So we do need a strategy to do this - what we can do, what we should do - and most importantly, what activities have a place in Joe and Christine's home. I've asked Christine for permission to set up a room - even if it's the back porch - where those who are interested can work on these issue.

In my discussions with people who do this for a living...I've learned we are dealing with strong forces out there. Strong and sometimes difficult but not impossible to move.

The advice I've been given is that letters - both personal and as organizations - to the key FDA players and your local congresspeople and senators CAN have an impact. Factually supported letters are effective, but your personal perspective as a person living with Her2+ cancer is also impactful.

I had a long discussion with someone on my flight to Italy about TDM1 - and realized that although she considered herself a breast cancer advocate she had NO CLUE what Her2+ was, or what that meant, and certainly nothing about TDM1. I'm sure this applies to virtually all of our elected representatives (and possibly, I fear, some in the FDA!). Educate them at every opportunity.

I posted contact info for these people (FDA and how to contact your representatives) earlier in this thread. If you have meaningful input, send a letter now - don't wait. Then send one AFTER the election as well!

If you do not feel confident enough at this point to do so, one of the supportive projects we are working on is to draft some key talking points...but many of them are also already contained within this thread. Be courteous and respectful in your communications (this forum is a great model for that). It's hard to win someone over to your position by calling them names.

So, if you can do something on your own (write letters to newspapers, get an interview, deluge your elected representatives) now, DO IT! If you would like to participate in setting up a broader strategy to make our voices heard on this and other issues, send me a PM.

If you're not ready to do either of these things and need some guidance/support, hang tight. Oh, and if you've ALREADY told me you're in for the strategic part (you know who you are!), you know there's no backing out now and I'll see you on FB and in SA.

ElaineM · 10-13-2010, 09:46 PM

Hi Chrisy,
Thank you so much for your efforts. I think a "room" or thread devoted to T DM1 is a great idea.
That way we can consolidate our efforts, concerns, and whatever information we have to share with each other regarding T DM1.
I have been quietly doing whatever I can do as an individual. I might be able to help with a small amount of research or do something related to a petition if I can. I am thinking we might be able to put something like a petition online. Those who wish to ask more people to sign it could print copies out for that purpose and send it to a specific location choosen by the majority of the members after they have collected some signatures. I would be happy to share any information I come across related to T DM1.
I too have found many people, including health care professionals who take care of breast cancer patients who are not familiar with T DM1. I tell them about about it whenever I think it is appropriate to do so.
In my mind whatever I have read and learned about
T D M1 makes me think of it as one of the best things that has been developed since Herceptin.
I know you are very busy, but please keep in touch and share whatever you can with us whenever you can.

schoonder · 10-14-2010, 06:27 AM

The 3rd line MBC T-DM1 phase II trial TDM4374g, which started mid 2008 used by Genentech to file for priority review, wasn't the only evaluation of this drug in this patient population. A similar phase II trial in this setting, TDM4258g, that got underway in July 2007 also had very positive data.
Is it possible that participants in this trial did have prior experience with treatment options Genentech per FDA failed to include in trial for which NDA was filed and if so, couldn't that data, in conjunction with positive results from multi-national 1st line MBC TDM4450g trial be used for FDA to reconsider their decision?

chrisy · 10-14-2010, 09:28 AM

I think the data from TDM4258g was made available to the FDA and no doubt the study participants had previously had multiple treatment combinations. But if their position was that they had not taken "all"...same answer.

That said, the FDA could decide at any time to reconsider their decision for any number of reasons.

schoonder · 10-15-2010, 11:52 AM

It appears a disconnect occurred between FDA and Genentech somewhere between first T-DM1 phase II trial for 3rd-line Her2+ MBC patients and second phase II trial which by design had greater emphasis on targeted aspects of prior treatments i.e. disease progression with both Trastuzumab and Tykerb/Xeloda regimens. What else could've been reason for conducting second phase II trial?

It's readily understandable that if T-DM1 showed efficacy where those prior targeted therapies, the ones most frequently prescribed because they heralded greatest promise to be effective, yet had now failed, that yes, a new life sustaining drug was brought into existence.

For Genentech to drag out their trial, searching for participants that had failed a number of infrequently prescribed treatments, ones not particularly suited for Her2+ MBC, i.e. lack of efficacy and high in toxicity, just to prove that T-DM1 was also superior to those regimens, wouldn’t that just be ludicrous?

Guess what, FDA totally failed to take into account targeted Her2+ aspect of this trial. Outdated directives didn’t provide FDA with an out to review T-DM1 3rd-line MBC Her2+ phase II trial results even though this agent clearly showed its pre-eminence over previously approved Her2+ targeted drugs.

ElaineM · 10-22-2010, 08:44 PM

T DM1 clinical trials that are active, not recruiting, or available from clinicaltrials.gov
http://www.clinicaltrials.gov/ct2/re...linical+trials

ElaineM · 10-24-2010, 12:54 PM

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.
__________________

11-11-2010, 08:28 AM

I am looking for women in New England who were told they could not have this drug after being approved under compassionate care. I have a Fox News station here willing to do an investigative report but we need women to come forward.
Susan

Barbara H. · 11-11-2010, 12:55 PM

Hi Susan,
I suggest that you call the breast oncology unit at the Dana Farber and mention what you want to do and why you want to do it. I would also mention that you received this information from this website and that the thread was started by a patient at Dana Farber who was on TDM-1 for two years in a trial. There is currently no way for patients at Dana Farber to receive this drug for compassionate care. You are dealing with patient privacy issues so if you are unsuccessful with receiving information or help, post again and I will contact my oncologist to see if he has patients who would be willing to speak with you.

This is a major medical issue because it is a miracle drug that is very easy to tolerate, and there are cancer patients who will lose their lives if they do not receive this drug soon. They can not wait until 2012. They have used up their chemo options. After a breast cancer patient has used a number of chemo drugs, the drugs that are left do not seem to work well or at all. This targeted therapeutic drug has a good response rate for this population.

Thank you for your help.
Barbara H.

ElaineM · 11-13-2010, 05:30 PM

http://www.clinicaltrials.gov/ct2/sh...+access&rank=1
and
http://clinicaltrials.gov/archive/NCT01120561

It looks like as of October 14, 2010 T DM1 Expanded Access is still available. I hope so. Please see my previous link to all T DM1 clinical trials and the phone number I posted for more information about T DM1 Expanded.