SoConfused wrote:is Regorafenib indicated for patients who are refractory to other lines of therapy or can newly diagnosed stage IV patients benefit from this drug as well?
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!
Gaelen wrote: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.
Any clearer?
Gaelen wrote:My understaning of expanded access is that usually the drug is only available to stage IV patients who have no other drug options. That's the basic process, but there may be rules specific to regorafenib that aren't clear yet because the program hasn't been formally opened yet.
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