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

Re: TMD1 is coming!
 

Yay!
Great news!
Thanks for sharing!
Denise

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Praise God & Amen!

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That is wonderful news Jessica!

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Best news of the day!!!!!!!!!!! Come on FDA...approve this for us...and fast!! Thanks for posting JML.

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Big question is..........did Genentech file for accelerated approval? Anyone know this??

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Jessica, Thank you for the heads up!

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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

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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.

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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!

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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.

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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

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SEE THE ANNOUNCEMENT AT THE TOP OF THE FORUM.

VIEW THE PRESS RELEASE HERE--

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

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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.

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Wonderful news.
Many thanks for posting.
karen z

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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 !

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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

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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

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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.

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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 ?