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Posted On: 12/17/2017 3:41:04 PM
Post# of 72443
My response to TIAB’s FUD on determining K’s MOA is meaningless.
Why want to know the exact MOA? I think it’s to take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21. If K is approved for ovarian cancer, it could be approved for any solid tumor without running additional trials.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .”
https://www.fda.gov/newsevents/newsroom/press...560167.htm
Why want to know the exact MOA? I think it’s to take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21. If K is approved for ovarian cancer, it could be approved for any solid tumor without running additional trials.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .”
https://www.fda.gov/newsevents/newsroom/press...560167.htm
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