Pemigatinib compassionate use
- This topic has 4 replies, 4 voices, and was last updated 4 years, 1 month ago by
.
-
Posts
-
Hi Stevieandme,
Adding to the very good suggestions provided below, please note that some of the trials have a cross-over provision for patients in the control arm group who are not receiving the new drug being tested. The cross-over provision offers the drug being tested to control patients whose cancer progresses while on the trial.
Regards, Mary
Although I haven’t had to deal with this directly, I’m pretty sure in the US the process goes like this- patient asks doctor, doctor agrees its worth trying, doctor asks/petitions company (and may at the same time petition patient’s insurance), then the FDA has to grant approval if not already done for that drug. So the doctor has to contact the pharmaceutical company. The doctor may think it’s not worth the risk and if so that’s the end of the plan (before it ever gets to the pharm company or FDA). Also, in the US, most insurances will not cover experimental treatments, which include compassion use drugs. That’s why the doctor has to petition for insurance coverage also. A lot of pharmaceutical companies will provide some type of relief or vouchers though if they believe their drug may help you. If I remember correctly one patient here was able to get Keytruda for free after the first couple of infusions showed benefits. You can probably ask this same question on the cholangio warriors patient facebook page for a more detailed response from patients who have taken this route.
The patient cannot apply directly to the drug company to ask for expanded access/compassionate use either in the U.S. or in the U.K. You are in the UK, correct?
Steve was accepted into FIGHT302 and randomly assigned to the chemo arm—which he has definitely decided he will not do, correct?
Chances are low that an oncologist would agree to apply for Expanded Access for pemigatinib. Patients or caregivers cannot apply to the company directly.
Chances are low that the drug company would agree to provide pemigatinib through expanded access without him having done the standard of care chemo first.
If he refuses to do Cisplatin and Gemzitabine and won’t change his mind, would he consider another FGFR2 inhibitor? If so, you could look at whether there is a trial site near you for PROOF (2 arms….either chemo or infigatinib which is an FGFR2 inhibitor) and hope that he gets randomly assigned to the infigatinib arm of the trial. Here’s the link for open Cholangio trials in the UK including the PROOF trial — https://ammf.org.uk/clinical-trials/
Has Steve’s doctor talked to you and Steve about how much longer he feels comfortable having Steve without treatment? Has the doctor talked to Steve honestly about what the risks are the longer he doesn’t have treatment? Has Steve said to his doctor, “if I refuse to do chemotherapy, and can’t get access to an FGFR2 inhibitor, what other treatment would you recommend I do first?”
Hi Stevieandme,
Here is information from the FDA website about expanded access.
https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients
There may be similar information on the manufacturer’s website or on the clinical trial announcement posted on clinicaltrials.gov.
From experiences reported by other patients and caregivers, it is important to be under the care of a doctor or medical facility that supports your interest in expanded access because there will be requirements placed on your medical providers related to the application itself, as well as to points such as administration and storage of the drug, record-keeping, etc. The FDA information explains the process.
Take care, regards, Mary
Steve has been accepted to Fight 302 trial but fell into the chemo group that he hasn’t decided to do yet.
I have learned that it is possible to request Incyte for Compassionate use of Pemigatinib. Steve would take this drug as the side effects are not so dangerous and it is very promising.
Any one maybe could help us how to request and/or access Pemigatinib from Incyte?
Any experiences about this?
Thank you
- The forum ‘General Discussion’ is closed to new topics and replies.