Questions about "Compassionate Use" for Trial Drugs
 

So, my brain and lung mets both show progression. My oncologist and I want to get tucatinib, which has just been cleared for individual access. I am wondering if anyone has had experience with applying for compassionate use. Does it take a long time? Does insurance pay for it? Is it difficult to obtain? I'm nervous about not being treated for too long; they took me off haloven and tykerb today, because they obviously were no longer working. Any advice, wisdom, experience, or encouragement would be gratefully accepted. Thanks!

Re: Questions about "Compassionate Use" for Trial Drugs
 

Katherine

I have no experience with this and doubt insurance will pay. Call Seatle Genetics at 855-473-2436. Ask about compassionate use. At leasy you will be moving.
Ill doublecheck the phone number . If correct Ill leave this post as is

Paul

Re: Questions about "Compassionate Use" for Trial Drugs
 

The number is correct but I forgot to write press option one

Re: Questions about "Compassionate Use" for Trial Drugs
 

The compassionate use program is closed right now - not sure when they plan to reopen, I hope soon. I'd call and ask.

Here's what I have learned:
Cascadian Therapeutics was the original pharma company that created Tucatinib. Cascadian was recently bought out by Seattle Genetics - sometime in the past 5 months.

Info:
http://www.seattlegenetics.com/pipeline/tucatinib

Contact info:
Seattle Genetics
425-527-4000
855-473-2436 (Option 6: Live operator)
contact@seagen.com
clinicaltrials@seagen.com

Your/A doctor has to file an IND, and takes a few weeks to get approved thru FDA and then the drug is provided as if you were on the trial.

I found out too late that the trial doc at UCLA actually had the compassionate use IND written and ready, she had done so for another patient. Oh well...

My doctor emailed me:
There is an intense amount of work that it takes to write a single patient IND which is what would need to do be done for application for compassionate use/expanded access But that in itself would not be the limiting factor. If we were able to get this in the next many months then it is essentially considered a phase 1 trial and there would be intense research nursing monitoring. I’m sorry but they said that they do not have the staff to do this outside of their ongoing phase 1 trials.

Hope this sheds light for you. Timing is everything!! Stay on it :)
Flori

Re: Questions about "Compassionate Use" for Trial Drugs
 

I am so sorry about the corner you are in. Can you go back on something that worked before like one of the taxanes with Herceptin? Can you convince your onc that maybe it turned hormones positive so you can try a hormonal too? I think they might try the Taxane and Herceptin to see and give alittle time to get a new trial or a compassionate use. I will continue to think for you

Re: Questions about "Compassionate Use" for Trial Drugs
 

Katherine

I dont know what state you live in but it might be a state that has a right to try law passed if Tucatinib has passed the stage one clinical tests which are basically toxicity studies. My guess is that these stage one studies have already been done, not 100% sure.
I researched the drug and the side effects are fatigue, rash etc but unlike the molecules that also inhibit the EGFR the diarrhea is less than Tykerb. The MTD has been established at 300mg twice a day. See if the right to try applies to you where you live.
no harm in trying