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Old 08-27-2010, 04:53 AM   #1
News
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Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-
ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

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Old 08-27-2010, 05:16 AM   #2
Lori R
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Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
UGH....I am extremely disappointed. After reading all the good results of this drug on the board, this was the next treatment on my personal list of options.

VERY frustrating to be so close.

I am sure my sentiments are shared by others.
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Double Mastectomy
Nov - Begin T+H
2008
Feb-Complete 6 cycles- T&H- NED
March - Continue - Herceptin Only
April - Rads for 6 weeks
2009
Continue Herceptin - Continue NED
April - Recurrance- 3 cm. Liver Met
May - Cryosurgery
June - November - Abraxane + Herceptin
Aug - PET/CT - CTC = 0 Back to NED
2010
January - Continue NED
July - Recurrance - 3 cm Liver Met CTC=1
August - Cryosurgery #2
August - November Navelbine
November - Back to NED - End Navelbine
2011
Feb - Recur - 4 cm Liver Met - Same Left Lobe
March Surgery it is -Couldn't get a clean margin
July - Confirmed continued liver involvement
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Old 08-27-2010, 09:14 AM   #3
chrisy
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Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
Disappointed does not even begin to say it. I'm trying to contact Genentech patient advocacy group as I write this. Here is the Genentech press release

http://www.gene.com/gene/news/press-...etail&id=12927
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9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial
5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
Last edited by chrisy; 08-27-2010 at 09:21 AM..
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Old 08-27-2010, 09:51 AM   #4
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Wink Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
Really terrible news for all her2 positive folks. Chrisy let us know if we can do anything. Is there a petition we can sign?
http://www.reuters.com/article/idUSLDE67Q03620100827
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Old 08-27-2010, 01:15 PM   #5
Chelee
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Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
I was shocked when I ran across this article last night. This is unbelieveable! From everything I have been hearing I really believed we would have it OK'd earlier rather then later. There are so many women that need this drug and now.

As Elaine already said...let us know Chrisy if there is something we can do? Where to call, write or picket...I'm there. (OK...the picketing might be over doing it...but I'm just saying.)

Chelee
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Results to FISH was unsuccessful--this happens less then 2% of the time.
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