Denied compassionate use of TDM1
 

I found out Monday that I have been denied compassionate access to TDM1 - my reasons for not doing Teresa were not compelling enough (based around family commitments and traveling distance)

I'm ok - half expected the news so for now I have come with my family across the world to Venice to celebrate my 40th birthday with a month in Italy. I will apply for the Teresa trial on my return home and pray that I am randomized to TDM1. If I am in control group we are not sure what treatment yet - maybe Abraxane and herceptin or maybe continuing with Tykerb and Herceptin which is what I am now doing to keep things under control while I am on holidays. I had a dose of herceptin on Friday and will continue to take tykerb - currently no chemo agent in the mix - but this trip was important to us so we brought it forward a month.

I have been told it could take 2 weeks to randomize me on my return so I'm all booked to start the process within 2 days of getting home. All 5 subjects so far at the research centre are getting TDM1. Roche did say I can reapply in the future.
I had a wonderful party with my dearest friends for my 40th - a 70's theme - i have changed my profile to a pic of hubby and I - ready to tear up the dance floor! (can't change it from my iPad - we looked fantastic! You will have to take my word for it!)
So today, as the family are sleeping off the jet lag - we will explore Venezia!
Amanda

Re: Denied compassionate use of TDM1
 

Amanda,

Thanks for the update. I'm thinking that the Tykerb/Herceptin combo probably is a better choice as the tumor had reponded well to Tykerb. And Herceptin ought to be able to take care of the 'stubborn' portion.

Enjoy your trip in Venice!

O and Happy Birthday!

Re: Denied compassionate use of TDM1
 

Hi Amanda, what a wonderful place and way to celebrate your big 4-0! I love Venice !!! And what a place to get lost, physically and mentally in such beauty. Really look forward to seeing your new profile pic! (I'm going to a friend's 50th on Friday night dressed as Amy Winehouse - I'm going as Amy Housewine!)

It would have been great to have received the compassionate use, but it seems you are well and truly organised for when you get back from holiday. Really hope you get the TDM-1, but for what it's worth I did really well on Abraxane/Herceptin, and quite tolerable (mind you the 70's wig will probably come in handy!)

Have a fabulous time away, and thanks for the update. I'm keeping you in my prayers....

Cheers Marie

Re: Denied compassionate use of TDM1
 

Amanda, Happy Birthday to you! I hope you and your family go nuts in Venice and have an awesome time! I will be hoping and praying for you that what ever you take you do great on. Gods blessings to you and your family. You are thought of often!

Peace my friend,

Nancy

Re: Denied compassionate use of TDM1
 

Amanda- sorry to hear about TDM-1. Grrrr. I am on the herceptin/tykerb combo and love it, so few side effects! I even tapered the tykerb down to 3 pills a day. It is super easy. Still don't know how well its working for me, but at least my cancer has been stable. :) Good luck!

Re: Denied compassionate use of TDM1
 

Amanda,

Many happy returns what a way to celebrate your 40th I may pass your post on to my hubbie to plan my 40th n a few years!!

Enjoy your hols relax have fun and get ready for the next phase on your return.

Jenny

Re: Denied compassionate use of TDM1
 

Amanda,
Happy Birthday! What a fabulous way to celebrate!!

http://www.gifs-paradise.com/animate...rthday-020.gif

Enjoy Venice! I'll be praying your Tykerb/Herceptin works its magic all through your holiday and that TDM-1 is waiting for you when you're ready.

Love and hugs!
Denise

Re: Denied compassionate use of TDM1
 

Amanda,

Happy 40th Birthday to you in lovely Venice!!

Enjoy your trip, plenty of time to regroup when you return.

all the best
caya

and eat some chocolate, it's good for you!!

Re: Denied compassionate use of TDM1
 

Just FYI... I don't know that Theresa is in compassionate use. Is that what you mean?

I do know that just TDM1 is in compassionate use, but yes you would have to be in the city where it is offered. I fly to Denver from Texas every three weeks until it is submitted and approved, or until it no longer works.

From what I understand (and I have experienced this first hand), TDM1 compassionate use is doctor specific. If a doctor says 'no' at one clin trial location, you need to find another clin trial location where they are 'reading' the written protocol more accurately, and apply there.

It might behoove you (if interested) to contact Sonali at Genentech for help. She has helped others, including me.

Sonali Padhi, MBA, MPH
Associate Director, Advocacy Relations
Genentech, Inc.
Office: 650.467.0842
Mobile: 415.269.7040
sonalip@gene.com

Good luck!

Re: Denied compassionate use of TDM1
 

I really love your " pluck ", the way you are going at tx options in such an assertive way. Have a blast in Venice, completely forgetting most of the cancer battle ! , except that tyk / herc has good power .
When you come back , I hope you get t dm-1 quick ! You can tell me more about exactly how , and by whom , you were turned down for comp use. helps us in our activist battle, we will take it to em' in the "Court of Public Opinion " !

Re: Denied compassionate use of TDM1
 

Hi Amanda
Have a lovely birthday in Venice. Wish you were coming to England then we could meet up.fingers crossed that things get sorted quickly when you get home
Hugs
Ellie

Re: Denied compassionate use of TDM1
 

Happy birthday Amanda and wish you many many more !!! Have fun in Venice and eat lots of taramatsu :)

Re: Denied compassionate use of TDM1
 

I'm sorry you didn't get compassionate use Amanda. I will never understand why they deny stage IV patients access. fYI though, TDM1 is going to be approved September 15th. That could be why they denied compassionate use. According to my onc. In SF, that date is a hard date, and TDM1 will be easy to get approved except for those newly diagnosed (opposite of pertuzumab). Have a wonderful trip, and happy 40th!!

Re: Denied compassionate use of TDM1
 

Thank you for this helpful information. By chance is your SF onc Hope Rugo? She helped me get herceptin because she said to me "you have a lot of disease". Is there anyone on this site who has connections to validate 9/15? I have been working on getting approved for the Th3resa trial and learned from the coordinator that soon they will stop randimizing--everyone approved will get Tdm1. But that is a little different from every onc being able to prescribe for those who have failed other stage iv cocktails. It would make my day if I could get it close to home. I think I read that someone knows the patient advocate at Genentech. Maybe she would confirm. There was so much hype when Perjeta was approved only to be told I couln't get it because I was treated for stage iv with tykerb/herceptin.

Re: Denied compassionate use of TDM1
 

Nancy - not Rugo, although I do see melisko at UCSF. Right now I am being treated by Garrett smith. He was our courtney's onc. I met him at her memorial service. He has met with the highers up at genentech, and when I asked how firm the sept 15th date was, he didn't hesitate when saying it is a hard date. I hope he is right!!

Re: Denied compassionate use of TDM1
 

Happy Birthday, Amanda! Completely enjoy your trip to Italy and forget everything else for now!
Love
Karen

Re: Denied compassionate use of TDM1
 

Congratulations on reaching the big 4-0!

Maybe God has something better in mind for you. I pray that you get into the trial and arm with TDM1. Perhaps if you had gone in earlier you might have been randomized to the wrong arm. I wish you the best.

Re: Denied compassionate use of TDM1
 

Hope your onc is right about 9 /15. I know first hand that some oncs spread rumors too. As recently as a few weeks ago, in July , ( 2 wks ? ), i heard that Gen hadnt even turned in the final package of data from EMILIA to This FDA. And even the " Old ", pre - Obama Admin. FDA took 3 -6 months to approve after getting final data. Final data was NOT ready when everyone was crowing about t dm-1 at ASCO in June .
I hope its true !! It will be here soon , and wouldnt it be something if , in the not so distant future, if you are even newly dx w/ her2 , and your FISH scale or other her2 measures are high, you could get t dm-1 right away !! And even better tx's someday !

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!

Re: Denied compassionate use of TDM1
 

Ahhhso... you applied in Australia for treatment in Australia? Yes, it might be different than the US. It's also entirely probable that Roche in Basel has different global guidelines for clumps of countries. As well, since I have been on TDM1 EAP for 1.5 years, things may have changed regarding approval also. I do know that I got-in in the US before they cut it off to collect/collate our EAP data into the other phase 3 data, and subsequently submit to the FDA in the US. (which we all hope happens soon, by the end of the year.

Good luck with the Theresa trial... do you know whether the doc will choose a treatment or put you on TDM1?