RE:RE:RE:RE:It's a bell-curve thing.CancerSlayer wrote: Enriquesuave wrote:
"If it becomes established that the majority of patients are CR after an optimized treatment, then no need for a PH3 IMO Drs can eventually use it off label as first line for HG CIS NMIBC. But yes to replace BCG by standard pathway would be to do a PH3 trial. For now BCG Unresponsive market is almost as big as about 70% of BCG treated patients eventually relapse and need other options. I would be happy with 50% market share."
Good points....
And when you consider the relatively high recurrence/failure rates for BCG-treated CIS NMIBC patients (approaches 40%), I think achieving a CR rate anywhere in the mid 60+% range may bode quite well for high rates of off-label use against CIS NMIBC (as a first line option) imo.
Daily off-label use is particularly high in the pediatric/neonatal fields where pediatric-specific data is lacking....a recent 10/2018 retrospective literature review from J Okla State Med Assoc. showed off-label prescription rates approaching as high as 95%.
Great discussion guys! I am optimistic like Gojo, though I might disagree on which group out there is 'rejecting science', lol. ;-)
Regarding BCG as SoC, Isn't it running into some sort of supply constraints? Manufacturing limitations? Also, I thought there was some discussion on here some time ago on a new 'shot' out of the UK, that would eventually make it over here, that is about 45%CR, which should replace BCG as SoC. I mean in a few years a NMIBC patient goes into their Doc and has the conversation, do you want this shot? Or do you want unpteen # of BCG treatments? These are mostly elderly folks so...
Yes, TLT's 1433 after Phase 2 approval, next year?, should cut into BCG's market share markedly, for the same reasons.