Tykerb..why the wait.

Lisa · 08-13-2006, 11:53 AM

Friends,

I applied for the Tykerb Compassionate care program back at the same time Irene applied. She has now started (thank goodness) and I'm still waiting. If I understood correctly, my onc told me Thursday that GSK is starting another trial, this time with Tykerb and Herceptin. So they are trying to determine which of the Compassionate care patients might be good for their trial.

I think I understood that. Has anyone else heard anything?

Love and light,

Lisa

chrisy · 08-13-2006, 12:09 PM

From what I have read, there are several trials with Lapatanib (Tykerb) which are now starting, one of them is with/without Herceptin. This is like the best AND worst time to be trying to get this new drug! The terms of the compassionate use program (EAP) do specifically state that pts would not be eligible for a Tykerb clinical trial. Great that there are so many trials, but its baloneysauce for the people who need to get the drug NOW. It is so frustrating to be waiting for them to decide HOW you should get the drug.

I pray that your doctors and the various GSK people involved will be blessed with wisdom QUICKLY and then get you and others who are waiting onto whatever will be the perfect miracle for each.
Take care
Chris

RobinP · 08-13-2006, 01:55 PM

Lisa,

Have you contacted GSK directly? Perhaps someon there could get the drug quicker for you. I would definatley check out the GSK website for contact name and numbers. Good luck honey.

Joe · 08-13-2006, 02:28 PM

We were supplied with a person at GSK who can facititate the applications. Unfortunately because of FDA rules, she can only talk with oncologists. Email me if you need the contact info.

Regards
Joe

Sandy H · 08-13-2006, 06:09 PM

This is how I understand it. There are several trials going on or about to start however, if they are not in your area then you qualify for the Tykerb and Xeloda under compassionate. I would like to do the Tykerb/Herceptin instead but there are no trials in my state. My oncologist applied June 12th and I am still waiting for the IRB at my hospital to do their part. I am suppose to hear tomorrow if I can have it. I am with you waiting this long should not be. I wonder if all trials take this long? No wonder people are dying before they get these drugs. I sent my doctor an e-mail letting him know how I felt about us being able to get these drugs while we are still alive! We don't need this stress! I feel bad for those such as Sherry who should have a chance to try it but the paperwork takes forever. For some two to three months is too long to wait and they never get a chance. If this is going to be released by the FDA this fall it is almost that now. This is just my feelings. THIS DISEASE DOES NOT WAIT FOR PAPERWORK TO BE DONE!!!!

Sandy H · 08-14-2006, 07:19 AM

Just another thought for Joe and anyone else. The oncologist have a number they can call but what about us patients? Who do we call-our doctor and he says he is doing all he can to push this through-there is no problem with GSK. Some times these people need to hear our cries for help otherwise they just don't get it. How can they if they are not in our shoes??? Guess, this is my venting for today as I am waiting for a phone call from the Data Manager letting me know their decision. I will let you know if I get that phone call and if not then tomorrow its my phone call to them. Have a nice day as I am meeting a friend for lunch she is a beast cancer survivor. hugs, Sandy

Joe · 08-14-2006, 09:33 AM

GSK has been made aware of the frustrations that many of our members share in receiving Tykerb. I have forwarded this weekend's posts to them.

There are strict FDA guidelines on how the pharmaceutical companies can interact with patients. They can only discuss approved treatments and drugs.
They can only discuss drugs under development with physicians and patient advocacy groups. We are here to act as your spokespersons. If anyone has any personal comments to make, email them to me and I will forward them to the right person.

Regards
Joe

Lisa · 08-14-2006, 02:44 PM

Joe,

My question for GSK is this: What is determining whether those of us who applied for Compassionate Tykerb receive it (assuming we've met all GSK requirements) OR whether they prefer us to go into a trial?

I gave my onc the GSK contact person and her number, so he may have an answer by this week's treatment on Thursday.

Love and light,

Lisa

IRENE FROM TAMPA · 08-14-2006, 04:27 PM

I hope I am giving you the correct info, but this is what I was told -

There is an ongoing trial in Gainsville that I was trying to get on earlier in the year. It is Tykerb/Herceptin. I qualified for that trial (the critieria for these trials make it tough to get into at times) When I first spoke to the doctor in Gainsville, I had to have had my last treatment and failed and had progression while on Herceptin. I had not been on Herceptin for a year so I started on Taxol/carbo/Herceptin. After a couple of courses, my tumors still grew so we stopped. I was about to get into that trial when I heard of a doctor in Tampa, where I live was applying for the EAP (Tykerb/Xeloda). I decided since that was the one released at Asco I would "wait" for this office to be opened.

I was told if there was a facility with an ongoing trial with Tykerb within 3 miles from me, they wanted me to go there for the trial instead of the compassionate use. They even indicated that they mapped the distance by Map Quest and I was only 2 miles away. My doctors office argued the point that I work and this would be a hardship for me to make that drive weekly.
They approved it and gave me a waiver. This just adding to my fustrations.

Once my doctors office had all of their paperwork in and approved (do contact Joe if you run into trouble. He was a big help with his contact) things went a little smoother. there was alot of paperwork going back and forth between them.

I would check with your doctor to see at what stage of the paperwork they are in. One thing I did do before waiting was to try to be sure that I met all their criteria. If you haven't already done so, have your doctor give you a copy of what GSK requires, as one little thing could throw you off.

Good luck to you and all trying to qualify. I DO know how fustrated I was with the wait and I agree.