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

Re: T DM-1 Approved !!
 

This is certainly wonderful news. I happened to be at my doctor's office when the nurse practioner came running out of her office to tell us the news !! She was very excited and jumping up and down. Many patients in Hawaii will benefit.

Re: T DM-1 Approved !!
 

This is such great news!!

Re: T DM-1 Approved !!
 

I jumped for joy when I heard this news. I believe that I was one of the first to be given this drug on this website. It was truly a miracle drug for me. I was on a stage one trial and received it weekly at a higher does than is currently given. I started the trial in Sept. 2007. It put me into remission. I remain in remission but had to go off it after two years because I developed lung inflammation. I then received herceptin with Tykerb and continue to be remission. At one point my insurance refused to cover the Tykerb, but my oncologist was able to convince them to allow me to continue this combination. Sheila was also very helpful at the time and I will never forget her kindness. I am enclosing my first post after my first infusion. For those who are interested, you can go to my history.
Kind regards,
Barbara H.
Post from Sept. 2007
Trial Trastuzumab-MCC-DM1 (I think it's working)
Hi Everyone,
I just wanted to give an update of the trial I am on. I posted it on the trial section, but thought that some members might not read it there and decided to add it to this forum. I just received my second infusion last Thursday. I had been off all treatment since the end of May because you have to be off treatment for four weeks to qualify. Unfortunately, as a result of no treatment, my bone mets had really started to grow and become painful. By August it became very difficult for me to sleep. In fact, one night the week before I started the trial, I only had two hours of sleep before getting up and going to school. This was all due to pain. No pain relievers would help and prescription pain relievers make me nauseous. In reality, I had been off chemo other than Herceptin since November when I had to have brain surgery due to necrosis. I really felt as if I was in bad shape and was desperate to begin this trial

My first infusion took all day. The needed blood work, consultations, and the infusion took 1 and 1/2 hours. Then I needed to be observed for four hours with constant temperature and blood pressure monitoring. After a final blood test I could leave, but had to return on Friday, Saturday, and Sunday for additional blood tests. This is a problem for me because I have bad veins and the trial protocol will not allow blood tests from my port.

During my first infusion my nose started running and I felt quite achy. Unfortunately, that night I had to give a speech and meet will my parents at Curriculum Night. It was difficult, but I did it. The next day I felt pretty awful, but went to school. By that evening I had a fever of 101F. At first I thought is was a reaction to the new drug, but now I think I caught a virus from my students. Three were out that week with colds and fevers, and by the beginning of the past week two of the other third grade teachers had it. I probably will never know for sure.

This past Thursday I had my second infusion and it was quite uneventful. The following day I was tired, but went to see "Wicked" that night with no problem.

Here is the good news. By the second night after the first infusion I was able to sleep with virtually no pain. After being in pain for two months, this feels like a true miracle to me. My hip is still sore during the day and I favor it somewhat, but I feel that this treatment is quickly making a huge difference. It is also very easy to tolerate. Therefore, if you are looking for a treatment option, I would definitely investigate this trial. I also wonder if there is anyone else on this website how is taking this drug.

I will continue to give updates, and will know more after I have my scans later this month.

I give my best to everyone. I have read everyone's posts, but just haven't had time to respond. The beginning of the school year is always very hectic.

Best regards,
Barbara H.

Re: T DM-1 Approved !!
 

I too am excited. And I too am concerned about my brain mets - they're still talking whole-brain radiation. I heard I'll be stopping my Tykerb once I start on t-dm1, but the Tykerb was supposed to help with brain. I know it's crazy thinking I really need to sell my business and train a new person before treatments that could affect my cognition and energy level, but the value of my business is linked to my skills. What if I can't do what I said I could do? Then again, I'll be worth a lot less underground!! Yes, thanks to the women on the clinical trials!

Re: T DM-1 Approved !!
 

So glad I logged on to see this!!!!!!!!!!!!!! WONderful!!!! Ceesun

Re: T DM-1 Approved !!
 

Karen,
I'm sorry...I didn't understand what you wrote to me. :( Are you saying that I would benefit, or that I wouldn't? Or are you saying that if I didn't have cancer below the neck, it wouldn't be in my brain? Or did I miss the point completely?
Confused (but not surprised by it!)
Denise

Re: T DM-1 Approved !!
 

My take on what Karen said: if you are Ned in the head, and have the rest of you below the head controlled, new baddies are less likely to wander north to your brain

Re: T DM-1 Approved !!
 

Soooo...
Once I'm NED in the head (soon, God willing)...then I could try TDM-1 to stay that way? But won't I always have to worry about tiny cells remaining in my brain to rear their ugly heads again if I go off Tykerb?
And so far...I'm still NED everywhere except my brain...so TDM-1 isn't really on my radar yet. Am I getting that straight?

At any rate...it's still REALLY exciting that it's approved for those of us who DO need it!!
Denise

Re: T DM-1 Approved !!
 

WOW, so glad to hear this. It will save millions of woman by the time a new and better drug is out.
Mario

Re: T DM-1 Approved !!
 

Read Saturdays Boston Globe , " FDA Approves Powerful New Breast Cnace Drug ", the best article we hav seen on T DM-1 so far. read it, and pass it on , to counter FDA propaganda. only journalist to interview an actual Stage IV Survivor !
We and Chrisy predictedThis FDA would put out press release on a Friday , (hopingworld would never hear , media forget by Monday. sadly , its happening , so e-mail your past media contacts , ask " Are you going to question FDA ? interview actual t dm-1 responders ? the researchers that are silent press wise ( This FDA is a punitive, defensive FDA ), but say T DM-1 will " revolutionize ' the tx of her2+ , ? What has happened to investigative journalism in this 30 ' attention span tv world ?
our local ch. 5 abc reprter was away, the station ran abrief blip on " Kadcyla " , ( what a name ! ), never mentioned T DM-1 by name, its history, Pts Rights , Protests. so Globe article, not perfect , is by far the best we haveseen so far , Praise it , thank Rob Weisman. encourage your other media contacts to follow suit. should be a 60' type story. note Rob's estimate of it helping 15,000 pts this yr , sooo, would it have helped 30,000 plus during This FDA 's 2 yr delay ?
he did get one thing wrong, said protests end, we never said that , and Dr. Hmburg is comin to town March 15th ...stay tuned

Re: T DM-1 Approved !!
 

we also predicted that This FDA would play up side effects, and they did ! all chemos have s/e.'s. this one has less ! and now pts can flex tx dosing , schedule to lower s/e like plats, red counts more. Lorrraine wants to go to once amonth , at 3.0 dose and will.

Re: T DM-1 Approved !!
 

Write ltrs to editor too !

Re: T DM-1 Approved !!
 

our personal plan is to stay on as higha dose as possible, adjusting carefully to raise plats a bit more, and hope steady dose will prevent brain mets . for those w/ hx of brain mets,now we can add tyk , other appr. drugs, to t dm-1, right ?

Re: T DM-1 Approved !!
 

Our thanks to those who pioneer , sacrifice in Phase I safety, toxicity trials like Barbara H. some in those trials got doses as high as 4.0, higher ?, today highest dose is 3.6, and some got it ( and KDR 's trial now get it) weekly !
we are asking t dm-1 responders , 6 months plus, to do a short ( 2 ') bio video, of your t dm-1 results. e-mail it to me , pmccartinjr@comcast.net . i will have our young techie activist couple put it on our website, http://stageivsurvivor.webs.com. to refute This FDA , won't it be nice someday to look back and refer to them as " That FDA " , 2009- (early ? )2013 , instead of "This FDA " we are more sad than angry with them, its an impersonal , " We Know best " attitude, and the Washington Establishment 's intransigence to change. but change is coming, we can't have 4 more yrs of this !

Re: T DM-1 Approved !!
 

Hi, Denise
What I've been told is that if you are NED from the neck down, it is unlikely that brain mets will occur. I guess it goes back to the circulating cell theory. And I don't think it's all to the story, or that it can blanket the population. Rather, it is a generally-held belief. Sorry if there was confusion there. I ask about it frequently as Kadcyla doesn't cross the BBB.
Wishing you the best,
Karen

Re: T DM-1 Approved !!
 

Phil,
You are so right on so many fronts about dosing. It is not easy at the level I'm on, but my onco said this is the weekly dose. Problem is what happens if we do lower the dose and the cells get out of the net, if you will. It'll be interesting to see how the drug is RECOMMENDED to be administered as approved.

Warm wishes,
Karen

Re: T DM-1 Approved !!
 

Wonderful news (wow, I kept hearing "February" at the conference- kind of pushing it but we will take it)!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Re: T DM-1 Approved !!
 

In theory, being NED in body below the neck, can keep the brain clear, but often NOT in practice.

Note the increasing number of Brain As First Site of Mets we have reported here.

Note the number of us here who have stayed NED in body on maintenance Herceptin, then have had brain mets appear while remaining NED from neck down.

Mets can be seeded during active cancer and sit there for some years (as in my case).

Any treatment such as IT Kadcyla (T-DM1) seems a little harsh and WAY down the road to me. Perhaps Perjeta as a direct treatment to brain has a possibility, but have not yet heard of that happening.

I certainly hope Tykerb is working for you, Denise! It is very hard to say when and/or if we might be out of the woods with brain mets. I still get a brain MRI twice a year, and would get one immediately if I thought I had any symptoms.

Re: T DM-1 Approved !!
 

This is good news as it opens up options.
It was not an effective treatment for me so my excitement is somewhat tempered as I know of others with limited results from this drug. It, like most others, does not work for all - this needs to be understood. My oncologists believed that Kadcycla could be used again for me but I would need further blockade - possibly with perjeta or even avastin. While I am excited at another treatment possibility (I hope I get to use it again as it was quite tolerable), I believe the very real issue for those of us with stage4 her2 disease is overcoming herceptin resistance be this with dual blockade, PI3k inhibitors or something else. TDM1 does not expand upon the need to develop other ways of blocking the pathway, it is simply a new way of using Herceptin. To say that it should be used in adjuvant therapy without testing it's efficacy against the current treatments (anthracyclines and taxanes of TCH) is wrong as these treatments are currently saving many lives - they need to trial this to see if in fact it is as effective for adjuvant care. There was similar excitement with tykerb and the adjuvant trials have now shown it to be much less effective and many people in the tykerb group now have stage 4 disease.

Bunty - The BCNA are currently lobbying for a few drugs (affinitor is one though not for her2 girls and eribulen) though I don't believe Roche have yet applied for Perjeta or Kadcycla - I might have a chat and see when they will be. Roche have become more amenable to compassionate access though. We need to jump on this.

Re: T DM-1 Approved !!
 

great news just great news!