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-   -   TMD1 is coming! (https://her2support.org/vbulletin/showthread.php?t=55617)

jml 08-25-2012 04:55 AM

TMD1 is coming!
 
Hi Friends~

Just talked to my sister (works in BioOnc @Genentech) and they have officially filed for TDM1 approval with FDA!
She didn't say how long the process would take, but I'm hoping it'll be approved with in 6 mos, at least in the beginning of 2013.

Thank God for more new drug combos available to us.

Keep the Faith!

Jml

NEDenise 08-25-2012 05:49 AM

Re: TMD1 is coming!
 
Yay!
Great news!
Thanks for sharing!
Denise

Redwolf8812 08-25-2012 07:56 AM

Re: TMD1 is coming!
 
Praise God & Amen!

'lizbeth 08-25-2012 08:01 AM

Re: TMD1 is coming!
 
That is wonderful news Jessica!

7andcounting 08-25-2012 01:41 PM

Re: TMD1 is coming!
 
Best news of the day!!!!!!!!!!! Come on FDA...approve this for us...and fast!! Thanks for posting JML.

7andcounting 08-25-2012 01:42 PM

Re: TMD1 is coming!
 
Big question is..........did Genentech file for accelerated approval? Anyone know this??

Pray 08-25-2012 04:36 PM

Re: TMD1 is coming!
 
Jessica, Thank you for the heads up!

dchips1 08-25-2012 07:58 PM

Re: TMD1 is coming!
 
I just did a 1 hour phone/web survey and I "figured out" the brochure , was for TDM1. They blocked out the drug name but left the cool graphics. They were surveying all across the community including nurses, patients caregivers, to get the brochure together.

Hope if they are working on the brochures that means its prayerfully a quick coming reality.
Darita

hutchibk 08-25-2012 08:19 PM

Re: TMD1 is coming!
 
It is fantastic news. I heard this possibility a couple of weeks ago, but didn't want to overstep my boundaries. I may be wrong, again... but while they are in process, I think Gene/Roche will open compassionate use again, and enroll in even more locations, all of the original ones they wanted to use before they had to shut it down and collect more data for the FDA.

chrisy 08-27-2012 02:03 PM

Re: TMD1 is coming!
 
According to the announcement at the top of each forum page, the filing was for priority approval, which should mean a 6 month review rather than 10 months. Have knows they have had data for long enough already!

MikeF 08-27-2012 06:32 PM

Re: TMD1 is coming!
 
Met with Barbs Onco today he claimed to have met with a drug rep from Genentech this morning and was told approval by the end of the year. Barb will start expanded access tomorrow provided the blood work done today allows.

Pray 08-27-2012 08:31 PM

Re: TMD1 is coming!
 
Mike, Gods blessings to Barb and you. I will be hoping and praying all will go well for Barb tomorrow. She has been through so much. Peace my friend, Nancy

Posts 08-27-2012 09:22 PM

Re: TMD1 is coming!
 
SEE THE ANNOUNCEMENT AT THE TOP OF THE FORUM.

VIEW THE PRESS RELEASE HERE--

http://her2support.org/images/storie...LIARelease.pdf

hutchibk 08-27-2012 10:28 PM

Re: TMD1 is coming!
 
And I believe they will be enrolling up to 300 more folks in the EAP... at all locations, including the original ones they first mentioned before they needed to cut it off for more data. At least I think this is correct.

karen z 08-28-2012 06:21 AM

Re: TMD1 is coming!
 
Wonderful news.
Many thanks for posting.
karen z

phil 09-04-2012 09:42 AM

Re: TMD1 is coming!
 
We T DM-1 activists would like to hear from T DM-1 ers who have gotten a good response, and would be willing to have thier stories told to Congress, the Media and Advocacy grps . Even EAP will only enroll so many, but so many, so many more need it. Wouldn't it be wonderful if This FDA approved w/in a month or two ? By end of Oct. ? We need to pressure them, their track record suggests they will wait until after the Election, and release a conditional approval, on a Friday night , to avoid publicity of thier rejection of it two yrs ago. Possibly excluding first - line. Even though its effectiveness on 1st line would be incredible !
We need to hear from you, contact me !

Lori R 09-04-2012 11:57 AM

Re: TMD1 is coming!
 
Phil,
I really wish I could help. I JUST started the TDM-1 trial that requires taxol in addition to TDM-1. I wasn't pleased but I could not wait for FDA approval. I am CERTAIN things are working. I won't get a scan for another couple of months and my story won't be compelling (yet) in terms of a lengthy duration at NED. (but I sure plan to get there)

Thank you so much for your continued support on this matter.

If you can think of any way in which my brief history with TDM-1 can add value, just let me know.

Lori

schoonder 09-04-2012 01:07 PM

Re: TMD1 is coming!
 
Phil,
Once in a blue moon FDA does approve a drug in expedient fashion; Xtandi, 3 months early. Will T-DM1 be a repeat performance? Emilia's results seen with PFS and OS end-points would make this a likely candidate. In this case approval would be for 2nd line Mbc.
http://www.cancernetwork.com/prostat.../10165/2099887

Nancy L 09-04-2012 04:39 PM

Re: TMD1 is coming!
 
I just went through weeks of screening for the Th3resa and got rejected today. The only active cancer they found during screening is the 3cm tumor in my right supraclavical area which I have been going through radiation for the past month due to intense pain. Turns out in the clinical trial setting, they must have active cancer that is measurable and it can't be in an area previously radiated. The clinical trial onc said I should wait and get a CT scan in November to understand the full effects of the radiation and then decide on a systemic drug--preferably T-DM1.

He also said T-DM1 is said to be available in Dec 2012. I think the oncs involved with the T-DM1 trials probably have inside information since it wll affect their business income.

This is my second recurrence. I took Tykerb/Herceptin for 3 1/2 yrs but based on how I have been feling for about a year, I think this combo stopped working a year ago. Dr Slamon advised me to get on a T-DM1 trial. I tried hard but no such luck for me.

Someone posted on this site that a SF onc said it would be available 9/15. Wouldn't that be nice.

phil 09-04-2012 06:32 PM

Re: TMD1 is coming!
 
Schoonder, nothings been expedited with this fantastic drug . its an indictment of the current system, that bureaucrats could get away w/ this. Completely ignoring you stage ivers who are the BACKBONE of research. without you , NONE of these Fantastic Drugs get Approved ! It demands an Investigation, and I will do all i can to see that that happens . We sure need your help. We owe it to all those who didnt geta chance at this drug in the past 2 yrs. Lori, your story will hopefully be one of the successes , to be told to the People when we change This FDA System.
nancy, if you needed radiation after tyk , you progressed on tyk ? can't you apply for exp access ?

Pray 09-04-2012 07:53 PM

Re: TMD1 is coming!
 
Nancy, I'm so sorry you were denied! Gods blessings to you. I will keep you in my prayers.

Nancy L 09-04-2012 09:34 PM

Re: TMD1 is coming!
 
Phil,

I asked the trial coordinator and onc if they would help me make a case for expanded access. They said once the rules are announced, they will let me know if they think I could qualify but they didn't sound encouraging. I'll keep you all posted if I learn anything useful about how expanded access will work this time around.

KsGal 09-04-2012 09:43 PM

Re: TMD1 is coming!
 
Im so sorry Nancy. ((hugs)) I know we are all excited about the possibility of TDM1 being approved on a fast track. I still worry. I was excited about Pertuzimab as well, and then when it was approved, its not for people who are stage IV like me. Im really happy for those who are able to receive it, but Im a bit selfish and I would like to share in all these cutting edge drugs for myself as well. Here's to hoping we will all be TDM1 eligible when it is approved.

Ellie F 09-05-2012 04:05 AM

Re: TMD1 is coming!
 
Sorry to hear this news. Hope and pray itwillbe available for all soon
Ellie

phil 09-05-2012 07:00 AM

Re: TMD1 is coming!
 
Nancy, while they "debate " possible exp access exclusions , what about applying for comp. use ? you can tell how ticked off , to put it mildly, that we are w/ all the bureaucracies stumbling , bumbling over such a miraculous drug ! One of our activism " planks " will be Flexible Treatment for Late Stage IV Pts , shorter washouts, keeping folks in trials even w/ " mixed response ", and for the pharma co's : If you think your drug is good enough to be considered for acc. approval, its good enough for comp use to late stage iv pts. If FDA rejects acc. appr., you finish the phase III trials that they want. Hopefully in the future we will have a 21st century FDA that can help get trials in that category to be reviewed more quickly, not 2 + yrs like This FDA with T DM-1.

Nancy L 09-09-2012 11:33 AM

Re: TMD1 is coming!
 
Phil, I had radiation to reduce the pain caused by the tumor pressing on the bronchial plexus. They told me the radiation would not eliminate the tumor. The problem is the way they write the inclusion criteria. You must have regressed on your most recent protocol, which for me they say is radiation, not tykerb. The trial coordinator for Th3resa said the tumor would have to start growing again to qualify for expanded access. But my husband is going to call either Genentech or Stockton tomorrow morning and plead my case.

I am curious---if the FDA is going to fast track and approve this year, why would Genentech set up EAP for just a couple of months???? I could understand doing so if it was available at all trial sites. But having only three makes access very difficult for most women. I didn't realize how screwed up the FDA is untill I got involved trying to participate in a clinical trial.

hutchibk 09-09-2012 11:58 AM

Re: TMD1 is coming!
 
That's a question for them when your husband calls, for your clin trial coordinator, or for Sonali at Genentech.

phil 09-09-2012 06:58 PM

Re: TMD1 is coming!
 
This Adminisration has un-leashed some FDA bureaucrats, who are hell -bent on "dotting every ' bureaucratic ' i ", punishing co's for some not finishing trials after acc. appr was granted yrs ago. So they revoke avastin, reject acc apr for tdm-1, partial apr for pert. FDA Press releases on Friday nights to avoid publicity. Bureucrats who were angry that gen. appealed revocation of avastin. Bureucrats who dozed off during avastin super -repsonders testimony. Note that all are Genentech drugs. So the co. is under the gun with This FDA. Who knows when t dm-1 aaproval comes ? and whether there will be conditions. could be Nov., dec. ? march ? gen has done the trials, so exp access gets it to some pts, is agood pr move. remember thye pay for the drug in access. I havent called Gen., to ask how many exp. access sites are open ?

hutchibk 09-10-2012 03:44 PM

Re: TMD1 is coming!
 
I would call Genentech/Roche, they will know locations. Yes this FDA has "it out" for the pharma company... you know how I feel about this FDA. Possibly TDM1 approval mid-Feb. Just one girl's opinion.


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