Topic: FDA "Breakthrough Approval Status"cut months-Years away.

Hi,everyone

if interest. As you know New approval drugs can be  for "off label use" for other forms of cancer.

http://www.fiercebiotech.com/story/jj-p … e=internal

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: FDA "Breakthrough Approval Status"cut months-Years away.

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,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

3 (edited by PCL1029 Wed, 13 Nov 2013 19:14:07)

Re: FDA "Breakthrough Approval Status"cut months-Years away.

Hi, everyone,

Here is the link from FDA with regard to the approval of the above "break through" drug.

http://www.fda.gov/Drugs/InformationOnD … 374857.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.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: FDA "Breakthrough Approval Status"cut months-Years away.

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

Re: FDA "Breakthrough Approval Status"cut months-Years away.

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/programrequirem … uglist.pdf

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.