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Re: Genentech receives FDA Refuse to File Letter for T-DM1
I spoke today with Kristin at Genentech (who had been one of Joe’s key contacts there) about today's press release on the FDA refuse to file letter for T-DM1.
She sent me a copy late last night in an email that began "This was really disappointing news and I am so sorry to have to share it". She also expressed concern that the Her2 support group gets the information and support they need, given how many folks there are on T-DM1 studies (which continue) or were hoping for access via approval soon.
Current trials are ongoing at this time, and patients who are receiving TDM1 through participation in studies will be able to continue receiving it. Overall, Genentech is still working though what the FDA decision means in terms of the “big picture” and I don’t know how this might impact EAP protocols yet – but she promised to keep us posted as more information becomes available.
Having met Kristin as well as others in the TDM1 group, I believe this is not just a "company" disappointment, but one that is also personal on behalf of us - the patients they serve. I also appreciate that she totally gets that "our" reaction is way beyond disappointment.
I’m still trying to come up with the right word for how I feel about this. Does anybody have a word for “really really really frustrated and angry at how many barriers they need to throw down between us who are fighting for our lives every day…and the weapons we need to win the fight”? There are a lot of words I’ve been using, but they’re mostly more general bleep words.
And I agree….we have to speak up now! We don’t have another 2 years to wait.
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Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
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
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