Sunday, December 17, 2017 1:17:26 PM
The safety and PK/PD data of K Phase 1 and Phase 2a can be referenced so oral K doesn’t have to start all over again.
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/pressannouncements/ucm560167.htm
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