What jumps out at me here is that they have a process to clearly screen for a specific element of the cancer and have a treatment that targets it. They recieved approval because they have the complete process to optimize treatment - screening and treatment.
Gee, sounds awfully similar to what an Australian Biotech is trying to do.
All RAC need is:
1. 40% CR rate
2. Screening assay that identifies patients where FTO is driving tumorigenesis
We already have a 40% CR rate. What we don't know is whether the patient population that responded did so because of their FTO status. Unless there is some undiscovered function for Bisantrene, my money is on FTO inhibition. The optimal situtation, which I feel is the most likely to play out, is that this response will be seen in numerous cancer types as well as in combination with other drug types. It's essential that the dosing protocol supports the long-term inhibition of FTO.
Ann: Impressive Bisantrene Phase 2 AML Clinical Results, page-97
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