T DM-1 Approved !!
 

Finally, This FDA approved " Kadcyla" ( TDM-1 ) for her2 + pts who have progressed on " herceptin and a taxane " , now many , many more lives will be saved, and pts like Lorraine can get the drug the way they and their doc want it, the healthiest way.
we will still fight for full approval for early stage iv pts, sparing them from taxanes ...

Re: T DM-1 Approved !!
 

YES YES YES JUST GOT THE EMAIL BRING IT ON


Karen

Re: T DM-1 Approved !!
 

Fantastic!

Re: T DM-1 Approved !!
 

This is wonderful news! Thank you so much, Phil, for everything you did to make this happen, and all the attention you brought to this situation. Also, thank you to all the ladies who participated in the trials. None of this would have happened if it wasn't for courageous people like you, who inspire the rest of us. <3 Might I just say, YAY!!!!

Re: T DM-1 Approved!!
 

YES, finally! Too bad there is not enough data yet on adjuvant, or enough juice to allow it to be a first-line treatment for Stage 4 (although there is a tiny loophole if someone progressed within 6 months after H and a Taxane).

On the back end tho, it's good to see it's not restricted (like Perjeta) to first or second line....so all those who have been fighting through multiple lines of treatment will have access.

Still wish it had been 2 years ago!

Re: T DM-1 Approved !!
 

What good news! It took so so long....
Phil, thank you for fighting for all of us.
And now Europe??? Anybody know?
Michka

Re: T DM-1 Approved !!
 

Whooo Hooo.....Such great news!

Yes, thank you Phil and all the brave trial volunteers.

Kim

Re: T DM-1 Approved !!
 

http://www.nytimes.com/2013/02/23/bu...g.html?hp&_r=0

New York Times article-
Phil, take note on the last line, something tells me the writer might have been referring to you? (Means you, Lorraine, and all the others have been recognized).

Today, when I got the text from a company rep about the approval, I jumped out of my seat in the waiting room of my treatment center. I felt such a sense of elation, but also of validation. Since I've been on this trial, two of the drugs have been approved, Perjeta and Kadcyla. It has not been an easy road, being so carefully monitored. But look at the reward. I am proud to have paved even one brick in the road for others.

Like my yoga instructor, Regina, says: "Service to others is the price we pay for being here."

Karen

Re: T DM-1 Approved !!
 

So Happy!!! FDA comes through!!!!!!!!!!!!!!!!!!!!!

Re: T DM-1 Approved !!
 

My doctor said he'd put me on it as soon as it was approved, so we'll see. I am not sure how long it'll take to filter down to clinics and if nurses need to be trained. But I am very happy and hopeful that it will give me some more time. :)

Re: T DM-1 Approved !!
 

Many many many grateful thanks to those who made this finally happen !!!!!

Re: T DM-1 Approved !!
 

This is wonderful news, and thanks Phil and all concerned for your amazing efforts. My onc recently offered me TDM-1 under compassionate use as it's not approved here in Australia of course. I chose to try Abraxane again (which seems to be working again thankfully). However, I wrote to our Federal Health Minister and this was the reply (for the interests of other Aussies reading). From what she says I think we need to work with Roche or the lobby groups. Cheers Marie

Regarding your query, in order for a prescription medicine, including an orphan drug, to be included in the Australian Register of Therapeutic Goods, an Australian sponsor is required to submit an application accompanied by scientific and clinical data to demonstrate the quality, safety and efficacy of the product for its intended use.

The Therapeutic Goods Administration reviews the data and will usually seek the advice of an independent expert advisory committee before making a decision to approve or reject a new product. The Australian Government is not able to compel a sponsor to submit an application to register a medicine in Australia and approval for marketing cannot be given in the absence of an application. However, due to commercial-in-confidence issues, the Therapeutic Goods Administration isn’t able to advise if there has been an application for either of the drugs you refer to and or where it's up to.

Thank you again for taking the time to write to me and I wish you all the best with your treatment. It is an onerous process and I hope you are surrounded by a wonderful support network.

Best wishes,
Tanya

Re: T DM-1 Approved !!
 

I have corresponded with Mr. Pollack at NYT. I dont see any reference to us in the online version. His article is the most balanced so far , but even there the warning about liver toxicity , death is not challenged. The FDA " Establishment " goes un-challenged. We have heard of only 2 deaths thru liver failure , early in trials, both with pre-existing conditions. there are platelet , red count issues , but many do not have them , and many, like Lorraine have found a way to manage them. overall side effects are much better than tyk /xel, taxanes . When Lorraine saw side effect stuff put out by This biased FDA , she said " I'll talk about side effects , how about fingers split open , bleeding all winter from tyk/xel, losing 15 lbs off an already skinny chemo body with awful gi upset " Thats the story that shoud be told. Dr. Snydermans NBC story tonight was very brief, pessimistic, ( "its not a cure , costly, bad s/e 's, blah , blah " ) she must have been briefed by This FDA. as the NYT says its costs are comparative to other tx's . we know s/e's are overall less than old chemos, and cure ? its too early to tell either way , but Lorraine and many others are yrs ned. if This FDA ever gets it to early dx stage iv , ned rates will go up. CNN article ? says its anew drug Its NOT a " new " drug, its been around since 2006 in human trials , and it was featured at San Antonio way back in 2009. We have to fight for our rights , against propaganda from This FDA Establishment . The Fight is far from over !

Re: T DM-1 Approved !!
 

WooHoo Phil!!!

Awesome. I am so thrilled. First Perjeta and now TDM1. I see real progress in the treatments available. I may never need them, but I am comforted by the increased options.

Cool Breeze, you aren't done yet. I have a feeling I'll be following your blog for a long, long time. And voting, lol.

Re: T DM-1 Approved !!
 

Yes, I'll talk about side effects too! I was on it for 3+ years and it was like being on vacation. In fact, I did a lot of vacationing during that time...

Seriously, it should have been approved long ago, and hopefully soon there will be a path to access as a single agent without having to do taxanes.

Phil, I told you it would be announced on a Friday:). But at least it was in the morning, so hopefully it will get some discussion.

Overall a good day, but you're right, the fight is not over.

Re: T DM-1 Approved !!
 

It is GREAT to get such wonderfull news.
Hope the Drug Controller here approves it

Re: T DM-1 Approved !!
 

Wow Phil, do you want to come and fight for the ladies in Europe! Don't know how long before approved by the EU then of course it will have to get past the bean counters at NICE!
Concerned that we at end up in the same boat as we did with tykerb!
That aside well done for for all your efforts
Ellie

Re: T DM-1 Approved !!
 

Yay!
What great news!!
Phil...well done!
All you ladies who braved the trials...THANK YOU, from all of us to follow!
My only sad thought was...I just wish it crossed the blood brain barrier...too bad for me.

But still jumping up and down for the rest of you!!! :) A great day for all of us!
Denise

Re: T DM-1 Approved !!
 

Denise, with BC spreading to brain a not so infrequent occurrance, how much longer will it be before t-dm1 is studied in intrathecal trials? If proven successful, i.e. a breakthrough technology, groundwork is now in place that enables a much faster approval process.

Re: T DM-1 Approved !!
 

Hey, Denise,
The brain issue is definitely a concern, for me and others. But I have been told that if you are non-hypermetabolic from the neck down, chances are cancer will not rise above the neck in this state. Now that Kadcyla is approved, I'll be checking on whether to add Tykerb.


OK, so Kadcyla party was yesterday. Now, let's move on, starting today, to get the next best thing (or better) approved. Next...

Warmly
Karen