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Re: Denied compassionate use of TDM1
Boy this approval stuff gets confusing!
Brenda - I am applying for the Teresa trial now (have been told I will be accepted). I am in Australia so I am not sure if the process is different here but we were advised we could request TDM1 under a compassionate use program (Pertuzamab too this way but TDM1 is our preferred choice currently) - we did this and we're rejected. My understanding is the decision is made on a global basis in Basel. I believe that they felt I didn't have good enough reason to reject the trial. I felt I had nothing to lose in trying this route first.
Even if there is FDA approval in the US it can take years to get TGA approval here. Teresa is currently my only alternative to have a chance at getting TDM1.
I am not angry about the decision - I will hopefully get it soon but for now I am well and enjoying Venice! We are off to Florence tomorrow.
I hope all of us will get the medications we require to manage this disease. I also hope that maybe herceptin and tykerb together will help me for a while yet. I am enjoying a chemo holiday!
Arrivederci!
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Amanda xx
40 year old Mum to three gorgeous kids - son 5 and daughters 8 and 11
Wife to my wonderfully supportive husband of 17 years!
22 February 2011 - Diagnosed Early Breast Cancer IDBC Stage2b (ER/PR -ve, Her2+ve +++) - 38 years old
(L) skin sparing mastectomy with tissue expander, axilla clearance (2/14 affected) clear margins.
Fec*3, Taxotere and herceptin*2 - stopped due to secondary diagnosis
June 24 2011 Stage IV - Skin met, axilla node, multiple lung lesions
Bolero3 trial - Navelbine, Hereptin weekly, daily Everolimus/Placebo
February 2012 - July 2012 Tykerb and Xeloda - skin mets resolved, Lungs initially dramatically reduced but growing again
August 2012 (turn 40!) tykerb and herceptin (denied compassionate use of TDM1) while holidaying in Italy!
September 2012 - January 2013 TDM1 as part of the Th3resa trial - lymph nodes resolved, lungs slowly progressing.
January 2013 - herceptin, carboplatin and Perjeta (compassionate access)
April 2013 - Some progression in lungs and lymph nodes - Abraxane, Herceptin and Perjeta
July 2013 - mixed response - dramatic reduction of most lung disease, progression of smaller lung nodules and cervical and hilar nodes - ? Add avastin.
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