Tykerb/Lapatinib -- approval? who is using?
 

I want to thank Joe and those who were at ASCO who helped get Tykerb / Lapatinib approved for compassionate use. I was wondering if there is anyone here who has been able to get it. Does anyone know of anyone who has had it approved for compassionate use?

I am getting an uneasy feeling about whether or not anyone is getting approved for it, even if they meet eligibility qualifications, as outlined in the brochure that GSK has written up. Several have written that they have contacted them but have not had any response. I know of at least one person who would have qualified for compassionate use who was told by a non-profit hmo that she could not get. I also asked my oncologist (non-profit hmo) and he quickly glossed over it and would not discuss.

If it has been approved for compassionate use, why are those trying to get it having such a difficult time? I am beginning to wonder if the program outlined for compassionate use might be bogus.

What comes to mind re. compassionate use programs is how many new drugs came about and were allowed to be used by aids patients. Almost any medication developed for aids won fast track approval. Those with aids can get almost any medication either for free or for a very small cost (50 cents/dose). Because of this aids is no longer considered a death sentence. Is this not discrimination?

It is true that those of us who are Her2 are now allowed Herceptin. But are we? I hope I am mistaken but read that those who have advanced stage IV and have received other treatments previously are not being allowed to have it? Thus, if that is the case, then they are not even being allowed Lapatinib. because they have not yet had Herceptin. By definition should compassionate use include all the above? Why aren't patients who might benefit from Herceptin being allowed to have it for compassionate use--or is that being done? And, if not allowed Herceptin, and they are Her2+, why can they not get Tykerb?

And, if Lapatinib is as effective and safe as studies claim, why is it so hard to get? Shouldn't we be allowed to try it before using more toxic regimens?
Is it a cost concern--is it too good? Would it bring about economic disaster to other pharmaceutical companies if it works so well that patients don't have to use the other, more toxic, and very costly drugs?

Also, if someone was on Herceptin and only given it for one year (because of insurance limitation), why can't they use Lapatinib if it is theortetically safe--at their own risk of course, based on current available information?

What can be done to speed up the process of those who might possibly benefit from Lapatinib gaining more easy to it?

I'm sorry I don't have answers to your questions. I am currently on tykerb, but am doing it as part of the clinical trial with xeloda. From the other posts I have read though, approvals for some compassionate uses are expected by the end of the summer.


Good luck,
Shell

From my understanding pretty much any stage IV patient (Her2+) who is not responding to their current treatment can qualify for Tykerb for compassionate use. I believe it is being give along with Xeloda for now. I am currently in remission so my Oncologist said that I would not qualify for it even though I am stage IV. I would love to get on it with Herceptin now and not wait till I reoccur..My Oncologist told me that they have been approved to get the drug, he has 2 patients that need it desperately. They are just waiting to recieve it. I will ask him thursday about it again...sherryg683

I hope you are wrong. I go to Pittsburgh Aug. 1st to see if I qualify.

I am Praying that I do. My liver is failing fast, My skin tone is yellow and some days my eyes look as if someone took a yellow hilighter and colored the sclerea!
The veins on my stomach and abdomen are becoming very prominate.
I have done everything I am supposed to do. I even had the nephrostomy done and tube inserted, even though I was reluctant to do so. I absolutely hate itl
Anyway, I am hoping that I can get on compassionate use, if not I think that my time on this earth is almost over. I am losing a pound a day. Oh well, cross your fingers and pray for us that need the drug.
I will let you knoe ehat happens Aug 1st.
Love and Peace
Sherry

My Mom is apparently going to get Tykerb through the Extended Access Program that I think I got the number for on this site. She gave the info to her clinic and they said the paperwork was complete and she could start in about a month. She is currently on Xeloda and Herceptin so I don't know if they will drop the Xeloda or drop the Herceptin. She has a history of progression on Herceptin which I think is what made her eligible. Hope this helps!

xoxo,
Britt

Not an expert
 

I am certainly not an expert in answering those questions, but in my CSI work these last few weeks this is what I found out.

I am stage IV for some years now with many recurrences. Conseqently I have taken many chemos with not much left out there for me left.
I have failed on the last several regimens that I have been on so I have pretty much met all of the critiria to participate in the EAP program. I think the only thing right now that could hold me back would be if there is a ongoing trial being conducted that I could get into.

My oncs. office is almost at the last stage of getting approved now, in fact I am praying that they may have the drug by end of week. I am going on 6 weeks without any chemo now and I have two active, growing tumors. Herceptin has failed me so this is another reason why I qualify.

I will let everyone know if and when the drug arrives. Please keep me in your prayers as I am at my wits end right about now thinking everything in the world is going on inside of me.

Speak to your oncs office about applying for the EAP program. If they can get approved, it might be faster then waiting on Food and Drug to approve for everyone's use. But that should be happening hopefully by the end of year or early next year. I pray before.

Good luck to all. I know how the wait can be.

I saw my oncologist last Friday and he said he expected Tykerb to be here the end of this week or first of next. I am getting it under the compassionate program. It would have been here by now but the President of the IRB was on vacation last week and back on Monday. I will be using it with Xeloda as that is how it has to be given under the compassionate. I am praying for you all that need this drug, especially Irene and Sherry. Sherry, my dear, I am so sorry you have to wait so long that is not fair. May God bless you during this most trying time. hugs, Sandy