Our T DM-1 Story Part 2 Tonight

[phil]

Ch. 5 in Boston, WCVB, will air another interview tonight w/ us at 11 EST. Hopefully they will include my part where I ask Pres. Obama to investigate His FDA's rejection of this dream drug 2 yrs ago.

[7andcounting]

Way to go Phil. I do hope they air you asking this important question. Is this only going to be on local t.v.? I want to watch it.

[Soccermom]

My thanks also, Phil!

[phil]

Story bumped to tomorrow, it happens !

[phil]

Story to air at 5:55 PM tonight, hopefully again at 11. Hope it sticks it to This FDA. Its galling to see Dr. Pazdur in AP article today, praising the drug he blocked for 2 yrs. And , yesterday, Dr. Winer at Farber calling it a dream drug , but couldnt fight for it.
You watch, Dr. Pazdur will crow over pertuzumab approval this wk. I bet he will move it up, to take spotlight off his bungling of t dm-1. The pert decision was a no brainer.

[KDR]

Phil,
I commend you for being on the frontlines and asking the provocative questions. I was not able to get the 5:55 PM live edition of Boston's news here in NY. Hopefully, you will post a link.
Speak soon,
Karen

[Ellie F]

Hi Phil
A link would be great then we could see it in England.Many here want these two drugs approved quickly. Unfortunately we always seem to be behind the states.
Ellie

[Rolepaul]

Great drug that took a long time to get to market. The linkage of the mayastine to the Herceptin was considered unstable by some, but the final method of attachment was known in the mid 1980s for use in diagnostic kits. I think there were patent issues with the linkage that ran out and let Roche/Genentech use it. However the problems with the linkers scared the reviewers. In addition, there was some attitude issues in the previous Genentech presentation that did not play well with the reviewers last time around. The transcripts of the hearing are public record and are worth reading. I might agree with the review board having an attitude, but so did the Genentech presentation team. The frustrating part is patients were the ones hurt by this. Time for pompous attitudes by government and industry to be put to the side for the good of patients.

By the way, Brain/Spine Mets will be the next issue with Her2 patients. I hope that we have found a solution to this issue which might affect 20-35% of the HER2+ patient family.

[KDR]

Rolepaul,
"By the way, Brain/Spine Mets will be the next issue with Her2 patients. I hope that we have found a solution to this issue which might affect 20-35% of the HER2+ patient family."

Do you mean that this will be another area of target?

Thanks,
Karen

[Rolepaul]

Karen,

Liver Mets Eradicated is incredible!

There is significant evidence of Brain/Spine mets being a risk factor if there are other areas of involvement besides breast. The Herceptin based treatments resolve non-Brain/Spine issues, but Herceptin does not get to the brain or spinal nerves at a high enough concentration to be effective. Xeloda/Tykerb will be effective in some patients, but less than 30% that have brain/Spine involvement. There is research (debated by some) that says there is a four to seven year period after tumor diagnosis in which Brain/spine involvement causes an issue that is then investigated. Past that time, the brain/spine was never involved. Prior to that time, other issues can overwhelm the woman being treated and result in loss of life. This was the case before Herceptin was widely used, and is the case if the breast cancer is not found early. That is why a treatment for the brain/spine involvement is so important, and why my wife being found to be disease free after such a high level of tumor involvement is getting some interest. I repeatedly say "MRI of the brain yearly from years 3-8 after initial finding". Now I add "and the spine." If Nina's regimen is found to be effective, it will likely help thousands of HER+ women a year. By the way, I worked on a project a long time ago in a land far away that was part of the building block for TDM-1 and Pertuzumab. This is a great drug series. I am wondering if there will be a new TDM-2 with a different drug that is attached to Herceptin. If so, I want credit.

[KDR]

Rolepaul,

Indeed, it is. Also note my last entry: Forever, please. Who knows how long this will go? I'm hoping this is the magic bullet for me, but I'm aware of progession in others on T-DM1, so to be fair, I expect anything.

Nina's regimen? What is it? You've got me wondering?

Karen

[yanyan]

I read that since Her2+ patients now have an overall longer survival, more brain/spine mets are diagnosed. In other words, in the past many passed away before they were hit by brain mets since in most cases brain is not the 1st place for mets. In recent years new drugs have prolonged many stage v patients with lung, liver or bone mets and some have achieved long remission. But the research on brain/spine mets haven't got much attention. I second it should be the next target !

[Rolepaul]

To KDR,
Nina had 80 mg Herceptin and 0.400 mg of Topotecan given via an Ommaya reservoir (think packet just above the hairline with a tube under the skull) via a syringe feed in a method called intrathecal administration. A second dose of Herceptin (125 mg) with 42 mg of navelbine in a second bag was given the next day via IV. This was done for 16 weeks on a weekly basis. This was a compassionate care protocol and nobody but me thought it would work (okay Nina also thought it would work). Results were promising within two weeks, and confirmed on the first MRI results at four weeks. Prior to treatment in December 2011, we were told to "make end of life decisions", while June 1 (167 days after "The Talk") she was told there is no evidence of disease via MRI or PET scan. The neuro-oncologist said she could not find a record of this ever occurring in her experience. I know of four others, with four that I have not been able to find, that had similar treatment (IT Herceptin at a dose above 50 mg), but the others all had whole brain radiation. Nina did not. I have access to information at a level that people say is similar to Liz Salander in the Girl with the Dragon Tatoo, but I also have a strong pharm background.

Yanyan is right. This darn stuff can hide for a while, but once HER+ women are past eight years with NED, they are not likely to see a reoccurence. It is this frightening 4-7 years after the initial finding that is scary and needs the brain and spine MRI. I will do everything I can to beat this disease as my mother died from it and it has fought tough with my wife and me.

I don't like to lose (Star Trek II Wrath of Khan)
Never Give Up (The Untouchables)

I am in the pharmaceutical business because I can help people, but currently work with non-cancer medications similar to Herceptin. If my medication is not given to a patient, they die. There is no other outcome. I take this personally as well.

[KDR]

Yes, I can see and feel your compassion in many ways. I have not heard of Topotecan but a co-patient at my facility has had Irinotecan (she's HER2 neg). A story such as yours is what we all desire and congratulations on your design of this regimen.
Wow, heavy stuff.
When you say, your medication, do you mean the one Nina had? If not, what?
Trying to stay alive, and need a card in my back pocket,
Karen

[Rolepaul]

My medication is for a problem called Alpha 1 Antitrypsin immunodefiency. The drug I am the engineer for is Prolastin.
Topetecan is a slight change on Innotecan which is a drug that was brought to market at Pharmacia (now Pfizer) while I was there. Funny how that works out.
There are a lot of cards that you can put in your back pocket. You just need to have someone show you all the cards. That is what I do. I find the cards. Keep on going down the road. Someone will always be there to give you a shoulder to lean against.

[Jackie07]

Found this article and thought it might be related/an update to the subject:

http://www.huffingtonpost.com/2012/0...n_1567791.html

[KDR]

What a pleasure "meeting" you...


Karen
Who Believes In The Cure