There is no such thing as a silly question when it comes to biotech and this is actually far from a silly question. Yes I think there certainly is a place for Bisantrene as a primary treatment, the problem is the FDA won’t let you run a trial where you test in the front line as they consider it unethical to risk a patient’s life by denying them an treatment that is known to be effective. You need to trial it as a second or third line treatment for R/R AML. Once approved you could run a new primary treatment trial, but not before you get approval for a later point in the treatment pathway.
If the MRD approach works out it won’t really matter anyway. Bisantrene would be licensed for treating MRD(+) patients (about 25%) and it would almost certainly be used off-label for the MRD(-) patients since they still have a reasonable chance of relapsing too. It would likely end up being used in as many patients as if it was a primary treatment.
Not considering off-label use is one area where @wombat777’s analysis of future revenue may be too conservative. It makes a big difference to the financial projections if you include off-label use - it will basically increase the potential revenue 4x on the MRD path.
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- 1993: 5 of a total of 7 (72%) patients achieved total eradication of their cancer (R/R AML)
1993: 5 of a total of 7 (72%) patients achieved total eradication of their cancer (R/R AML), page-25
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