Re: Anxiously Waiting
 

I keep a notebook titled " FDA Blocks Life saving Drug ". You may already do the same. helps me to jot down chronological delays due to FDA , and includes the other " players " in this System, including Genentech , Partners IRB , Congress, Media, Doctors, Big Advocacy , etc. Focus on This FDA, who talks with you , who refuses to ( the decision-makers ), etc. For a future reckoning, perhaps via Sen Hagan , others.
Most importantly , we went through a similar crazy few weeks in 2010 , thankfully our doc was completely in our corner, ( once she saw we wrer comitted enough to go Va. just for enrollment ) giving low dose adria, considered tyk too, checking labs like white count , LFT's etc. every week, to get Lorraines counts up to standards, right up to the 2 week washout that exp access required . be assertive , politely question EVERYTHING , i. e. what is their expected washout time frame ? , etc. I personally would think it mimics exp access , 2 weeks. Be the " squeaky wheel ". e-mail me at pmccartinjr@comcast.net , if you want. we can talk.

Re: Anxiously Waiting
 

See on another thread , some say t dm-1 could be approved Sept 15 , hope thats true, but i know first hand that even oncologists pass along rumors .
If true it would be AWESOME !! I'll believe it when we see it . By This FDA standards it would be very quick, i dont know that they have even gotten the final data from Gen yet. It is Coming !!

Re: Anxiously Waiting
 

If I understand and am not wrong, a clin trial coordinator I know says that a look at data would be potentially in Nov/Dec at the earliest for TDM1... they have to file a BLA first, and that usually takes up to 6 months. If FDA likes what they see, they it would gain approval. Don't know where it is in the pipeline right now, but I will ask.

Re: Anxiously Waiting
 

Finally heard from Barbs doctors office today, the FDA finally approved her for the TDM-1 compassionate access. We were told some papers had to be signed by lawyers representing the practice administering the drug which should happen in the next 24 to 48 hours and we should see the drug here next week. We canceled here scheduled treatment today for Navelbine and Herceptin knowing that she wouldnt be able to do TDM-1 soon if she had Herceptin today. She and I are excited to get this in her system and were praying it does what its designed to do. Thanks again for all the encouraging words.

Re: Anxiously Waiting
 

Mike, so happy for Barb that she can get tdm-1. Glad she can start next week--hoping she sees a great response to this drug.

Re: Anxiously Waiting
 

OH, SO glad to read this latest positive development. I am sure it was time consuming and a lot of work, but that is the only way to punch through such barriers.

I believe that Brenda is right about the time frame for T-DM1 approval - Sept 15 is several months TOO early. Once Genentech has something more difinitive, I am sure we will be hearing on this board.

Re: Anxiously Waiting
 

Happy for you and your wife, it is a powerful drug for those w/ high overexpression of her2 . My wife is well into her 21st month , about 10 months NED. Some others are twice as far along as her.
Sept 1 will mark TWO Years of FDA delay on T DM-1 . It galls me to hear Pres. Obama last week , " making a pitch to women voters " , ( Boston Globe ) , saying that healthcare issues " resonate " w/ him because of his mothers battle w/ breast cancer 20 yrs ago, " I often think about what might have happened if a doctor had caught her cancer sooner ". I feel for anyone whos lost a family mbr to cancer, but if he only knew what His FDA is doing w/ drug approvals ! Someday soon he will !

Re: Anxiously Waiting
 

Mike,
This is such exciting news! I'm so happy for both of you!

Please give Barb my best, and remind her that we're all behind her...praying for her, and sending warm thoughts.

Clearly, you are a devoted, and loving husband! Your relationship is inspiring, and I'll be adding prayers for you too!

All the best,
Denise

Re: Anxiously Waiting
 

You are an amazing guy---so happy for your family that Barb at least gets a chance at a drug that might work. That is all any of us want--just a chance. Could they make this any more stressful?

I wonder if you would be willing to share the letter that finally got compassionate use approved for your wife. If approval doesn't happen soon I am going to try this route and I would like to see how to write a request that gets a yes answer. Thank you. My e-mail is nana@lamarca.org.

Your family is in my prayers.

Re: Anxiously Waiting
 

Great news Mike! So happy for Barb and your family.

all the best
caya

Re: Anxiously Waiting
 

Mike, how wonderful for you and Barb! I will be hoping and praying it works quickly for her. Gods blessings to your family.

Re: Anxiously Waiting
 

Im so happy for you both. Every time someone fights and wins, it's a victory for us all. The time will come when I will need this drug, and many others, and you are paving a road others may need to follow until this drug gets approved. Please keep us updated on how it all goes...Im certainly sending lots of prayers and positive energy. :)

Re: Anxiously Waiting
 

Mike,

Thanks for sharing the good news. There're always obstacles in life. But 'love never fails'...

Re: Anxiously Waiting
 

So much for 24 to 48 hours! We were told last Tuesday that thats how long it would take to get the papers signed. After several calls Monday and Tuesday I recieved a call late yesterday saying the papers were hand delivered to someone in Charlotte and we should hear something by the end of the week. You have to wonder if it was their husband or wife if it would take a week to get the papers signed. So here we are again anxiously waiting to hear when Barb can go get her first TDM-1 treatment. Its all been approved we just cant seem to get it here fast enough. I was told a long time ago that praying for patience can have painful consequences but I sooooo need some right now.

Re: Anxiously Waiting
 

This seems like a good time for my favorite mantra, "keep the faith" You have been such a soldier, so stalwart. I know this good thing will happen for you both. God bless.

Re: Anxiously Waiting
 

TDM-1 will be here tomorrow 8/24 appointment with Onco Monday 8/27 for labs and sign consent to be a guinea pig and 8/28 Start TDM-1
Hallelujah

Re: Anxiously Waiting
 

Yippee!!

all the best
caya

Re: Anxiously Waiting
 

Yay!
Thanks so much for letting us know!
All the best to both of you!
You made my day!
Denise

Re: Anxiously Waiting
 

Hallelujah is right!

Re: Anxiously Waiting
 

At last! Woohoo!