FDA “Breakthrough Approval Status”cut months-Years away.
- This topic has 4 replies, 3 voices, and was last updated 10 years, 8 months ago by
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Hi, Scott,
I read the ibrutinib package insert and find nothing relate to CCA.
however I find the following link of orphan drugs and approval list as of 9/3/2013 to be of some value ; item #7 is for liver and ICCA and be honest I don’t know Pentamidine will works for liver tumor.http://www.hrsa.gov/opa/programrequirements/orphandrugexclusion/orphandruglist.pdf
God bless.
Percy,
Is there any research that indicates this drug might be active against cholangio? I did a quick search and didn’t see any.
Great to see things get approved so fast and work so well on a tough cancer!
Jason
Hi, everyone,
Here is the link from FDA with regard to the approval of the above “break through” drug.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm
Your tax dollar is truly at work for you and the pace is faster for approval of new cancer and immunotherapy agents if the results are as good as the FDA link suggested for ibrutinib ORR=>60% and LONGER disease progress free period.
God bless.
I spoke with an FDA representative this morning. There are models we can follow for this type of approval and others that are still in development. Overall though, it will take input from the patient community and input from researchers and physicians. In regards to clinical trials: a secondary endpoint will be taken under consideration which then, if met, can drive accelerated approval. The good news is that we are not at a standstill.
Hugs,
MarionHi,everyone
if interest. As you know New approval drugs can be for “off label use” for other forms of cancer.
God bless.
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