RE:RE:RE:RE:RE:Critical Shortage of BCG and Adverse Reactions to Treatment
vestor111 wrote: Interesting H-doc thanks for the insights. With the BCG supply issues alone, it seems "off-label" applications may come sooner than later in some markets where BCG is in short supply and/or very expensive.
Dr. G put the number of BCG applications averaging 27 treats (if memory serves but on this order). Just the time savings alone might justify "off-label" treats.
Yep, between BCG supply shortages, BCG toxicity & BCG's extended treatment/maintenance regimen (12+ months), I see lots of potential for our commercial success. I also believe for those patients who did not attain a CR post first treatment (& hence removed from the trial), a significant portion of them (if not all of them) likely experienced tumor shrinkage (or an "objective" response). If/when we get regulatory approval, those patients would still be excellent candidates for an additional/second treatment imo, especially when you consider the lower-standard/undesirable alternatives (chemo, checkpoint inhibitor(s) or bladder removal).
"Real world" medicine (as opposed to the regulatory world) is truly an art...guided by sound evidence, yet allowing for sound judgment. For novel therapies that have successfully graduated from the confines of the FDA, the definition of risk/benefit or potential success broadens. IMO, docs wouldn't hesitate to offer a second TLT treatment in the real world, especially if the first treatment accomplished a reasonable "objective" response. Good luck...