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Old 12-09-2012, 06:59 AM   #1
HopeAbides
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Compassionate Use Criteria for T-DM1 by Roche

Hi All,

I've worked really hard to get the exact criteria for compassionate use of T-DM1.

As most of you know, T-DM1 is under FDA approval process and may available in the market by Feb 2013, if everything goes fine.

For anyone who would still need T-DM1, being unable to participate in clinical trials, here is the info I got, direct from the company - This is the compassionate use clause where a drug can be provided even before the FDA approval.

Hope it helps.

Roche is providing T-DM1 on compassionate basis for patients who have exhausted all possible current options of treatment.
Following is the eligibility criteria for Compassionate Use of T-DM1 in HER2 positive metastatic breast cancer patient. The patient:
• Does not participate currently in any clinical trial
• Has received at least two lines of trastuzumab (herceptin) containing regimens with two different chemo backbones(*) for their metastatic disease(TML)
• Has received in addition at least one line of Lapatinib for their metastatic disease
• Patients must have documented recent progression on last treatment
• Patient must be able to tolerate the Compassionate use of T-DM1 therapy
(*) Anthracyclines, taxanes and capecitabine must have been used for their metastatic disease, unless medical reasons preclude the administration of one or more of the above agents.
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Old 12-09-2012, 01:08 PM   #2
StephN
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Re: Compassionate Use Criteria for T-DM1 by Roche

Thank you, HopeAbides.

We have been posting the T-PAS (T-DM1 pre-FDA approval) sites that have been opening all over the country this past year.

It is good to have the inclusion criteria here, as well.

Check under the Clinical Trials & HER2 Group Forums here for "Stickys" at the top of the treads for those sites.
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Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 12-09-2012, 02:50 PM   #3
ElaineM
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Wink Re: Compassionate Use Criteria for T-DM1 by Roche

Thank you for posting this for all of us.
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Old 12-15-2012, 10:29 PM   #4
HopeAbides
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Re: Compassionate Use Criteria for T-DM1 by Roche

Hi All,

Just wanted to know if there is any recent progress on T-DM1 approval by FDA. Waiting with bated breath as there are no clinical trials available in India till now.

Anyone with any leads will surely be of much help. They are saying January, but that could be delayed.

Thanks
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