abuttigi wrote:Gaelen, can you expand a bit on what an expanded access program is? When I asked the oncologist about this drug, he said we may have access through one of these programs, but I don't understand what that means. Thanks!
I'm going to default to Wikipedia, here, even though it's not usually one of my preferred sources. However, this article
compiles the FDA rules for expanded access and a description of what the process is from the drug company, physician, and insurance angles all into one pretty good summary.
The key thing is that for most expanded access, the patient will have to be Stage IVE, have had to have progressed on all standard therapies, and have some factor which makes the patient ineligible for a standard clinical trial in order to qualify. And the physician administering the Expanded Access program will have to collect data and report it to the drug's principal investigator just as if the patient were participating in a clinical trial. The drug's final approval is conditional upon the proper reporting of this off-study, pre-drug-approval data.
Be in harmony with your expectations.
- Life Out Loud
4/04: dx'd @48 StageIV RectalCA w/9 liver mets. 8 chemos, 4 surgeries, last remission 34 mos.
2/11 recurrence R lung, spinal bone mets - chemo, RFA lung mets
4/12 stopped treatment