T DM-1 Approved !!

[Barbara H.]

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.

[ElaineM]

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.

[phil]

the recommended tx schedule will probably be 3 weeks, dosing starting at 3.6. but whats exciting is that now all that can be flexed per pt response. should ameliorate some s/e 's like plats.
i have an issue ( u can tell i have alot of issues !! lol) , with This FDA 20th century trial system in the 21st century , with 21st century drugs. how long will we wait for trials comparing taxanes to t dm-1 ? yrs ?? ridiculous . we know those drugs inside and out , as if taxanes were any where near as good as t dm-1 . they are not. most of the t dm-1 success stories i talk with are not posting, and probably fewer than 2,000 pts have even got to try the drug , many , like Lorraine, after yrs of tough chemos, lots of mets. it is not 100 % , somewhere in mid-range 50-60 % , now more can get it w/ flexiblity , not get kicked off trials for lung irritation or liver irritation, etc. more will get it after around of taxane only, so rate of successs will go up. it may very well be acure for more and more, and now u can add other chemos to it , off protocol.
but how many yrs until adjuvant studies are completed in his System, Dr. pazdur and his team are know it alls, pushing OS , longer trials , NO SENSE OF URGENCY WITH TDM-1 ! some estimate 45,000 Stage iv's could have tried this drug during that time. when will perjeta get to Stage IV ?? Investigate This FDA !

[phil]

I think 9,600 $ per dose, every 3 weeks , un-fortunately. Comparable to other recent tx's. Gen. may help some with income issues.
Wish This FDA did give proper sense of urgency to this drug . did they have to reject using expanded access data back in 2010 ? never think about shortening the trail over the past 2 and a half yrs ? giving t dm-1 any special consideration , based on the great stats in 2010 ( far better than tyk. , which previous admin. gave acclerated appr to ) ?
Did they have to take 6 full months for a " priority " review , with data last Sept. saying that 65 % of EMILIA pts getting t dm-1 had lived TWO YRS or more ??
No , but they did, because its not their wife or daughter, sister.
What have u heard about Perjeta getting to stage iv , since partial approval last June ? How urgent is This FDA with that ?
Didnt the old FDA stop the Phase III trial for original Herceptin before it finished ? What excuse do they have in 2102 ?

[phil]

I think 9,600 $ per dose, every 3 weeks , un-fortunately. Comparable to other recent tx's. Gen. may help some with income issues.
Wish This FDA did give proper sense of urgency to this drug . did they have to reject using expanded access data back in 2010 ? never think about shortening the trail over the past 2 and a half yrs ? giving t dm-1 any special consideration , based on the great stats in 2010 ( far better than tyk. , which previous admin. gave acclerated appr to ) ?
Did they have to take 6 full months for a " priority " review , with data last Sept. saying that 65 % of EMILIA pts getting t dm-1 had lived TWO YRS or more ??
No , but they did, because its not their wife or daughter, sister.
What have u heard about Perjeta getting to stage iv , since partial approval last June ? How urgent is This FDA with that ?
Didnt the old FDA stop the Phase III trial for original Herceptin before it finished ? What excuse do they have in 2012 ?

[dearjilly]

This is such great news!!

[A. L. Pendley]

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!

[Ceesun]

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

[NEDenise]

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

[chrisy]

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

[NEDenise]

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

[marvass]

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

[phil]

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

[phil]

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.

[phil]

Write ltrs to editor too !

[phil]

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 ?

[phil]

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 !

[KDR]

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

[KDR]

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

[karen z]

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