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Old 09-02-2013, 10:42 AM   #1
Lani
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Subcutaneous herceptin gets EU approval

As I said in a previous post, a Genentech/Roche representative I met at ASCO
said they have no intention to file for approval with FDA any time soon (not sure why not)

http://www.reuters.com/article/2013/...98103A20130902
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Old 09-03-2013, 04:39 AM   #2
Ellie F
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Re: Subcutaneous herceptin gets EU approval

This is the first hurdle for us in the uk! We will have to see if NICE approves it!
Ellie
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Old 09-03-2013, 06:58 AM   #3
sarah
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Re: Subcutaneous herceptin gets EU approval

this sounds great! I wonder if they did this now in order to keep the patent going, still it's very good news.
sarah
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Old 09-03-2013, 09:17 AM   #4
michka
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Re: Subcutaneous herceptin gets EU approval

Thanks Lani. This is really good news for all patients.

Why are they not filing for FDA approval? I don't always understand what the labs are really doing. For TDM1 they pushed in the US but we are still waiting in Europe and they do not seem to be in a hurry. For this new form of Herceptin it is the other way around.
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08.2006 3 cm IDC Stage 2-3, HER2 3+ ER+90% PR 20%
FEC, Taxol+ Herceptin, Mastectomy, Radiation, Herceptin 1 year followed by Tykerb 1 year,Aromasin /Faslodex

12.2010 Mets to liver,Herceptin+Tykerb
03.2011 Liver resection ER+70% PR-
04.2011 Herceptin+Navelbine+750mg Tykerb
06.2011 Liver ned, Met to sternum. Added Zometa 09.2011 Cyberknife for sternum
11.2011 Pet clear. Stop Navelbine, continuing on Hercpetin+Tykerb+Aromasin
02.2012 Mets to lungs, nodes, liver
04.2012 TDM1, Ned in 07.2012
04.2015 Stop TDM1/Kadcyla, still Ned, liver problems
04.2016 Liver mets. Back on Kadcyla
08.2016 Kadcyla stopped working. mets to liver lungs bones
09.2016 Biopsy to liver. no more HER2, still ER+
09.2016 CMF Afinitor/Aromasin/ Xgeva.Met to eye muscle Cyberknife
01.2017 Gemzar/Carboplatin/ Ibrance/Faslodex then Taxotere
02.2017 30 micro mets to brain breathing getting worse and worse
04.2017 Liquid biopsy/CTC indicates HER2 again. Start Herceptin with Halaven
06.2017 all tumors shrunk 60% . more micro mets to brain (1mm mets) no symptoms
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Old 09-05-2013, 03:49 PM   #5
tricia keegan
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Re: Subcutaneous herceptin gets EU approval

Thanks Lani!
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Dx July '05 IDC 1.9cm Triple positive 3/9 nodes positive
A/C X 4 ..Taxol/Herceptin x 12 wks then herceptin 1 yr
Rads x 36 ..oophorectomy August '06
Currently taking Arimidex..
June 2011 osteopenia/ zometa x1 yearly- stopped Zometa 2015 as Dexa show normal bone density.
Stopped Arimidex July 2014- Restarted Arimidex 2015 for a further two years on the advice of my Onc.
2014 Normal Dexa scan
2018 Mammo all clear, still NED!
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