Does that mean I can use Lysol off label? Somewhere I heard that might also be an option for treating my COVID infection; not sure where I heard it, but someone said it might, but not sure who? :)
Seriously, the question is first, does a biologic fall under the same general regs for off label use as a drug? And second, since D and L are administered differently and the tumor tissue is different (Ex’s argument), wouldn’t this somehow be a different approval process?
For instance, in terms of safety, how do we know sarcomas react the same way as GBM cancer cells? In some way, by pulsing dendritic cells from different tumor types, in effect, is that creating a different type of vaccine?
Also, would a BP pay for an unproven off label indication? Would doctors and their insurance carriers be skittish about malpractice exposure?
By the way, at my first ASM I spoke with a clinician who took part in the colon cancer (if I recall correctly?) trial, and she was almost certain that the vaccine works for that indication. Of course she was blinded, so could not know for sure.
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