RE:RE:RE:RE:RE:RE:Signing up new trial patientsEoganacht wrote: Hopefully there will be a way to get to TLD1433 pdt as a first-line treatment for NMIBC before too long. Maybe as an off label use after approval for BCG unresponsive NMIBC, or maybe with the new "Project FrontRunner” As the FDA oncology chief said,
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We really want people to be looking at accelerated approval not in the most refractory populations,” Pazdur said, “but let’s move these drugs up to an earlier disease setting as their first approval in randomized studies.”
Gman620 wrote:
I think from a 'practical' perspective, if the FDA approves early use of this INSTEAD of BCG, the time spent suffering through 4 or 6 BCG treatments could be given to this one instead, with the same or less overall risk, and the TURBT can verify pretty quickly if it's working or not, using the same window of time, even before the second treatment.
I'm likely preaching to the choir, but I'm still using Keytruda as our "single-agent" comparator...a drug that achieved a 12 month CR in only 19% of patients. If we hit any mark higher than that, I don't see how the FDA could deny our ACT, especially when you consider it would provide a better/less burdensome single-agent option when essentially no others exist.
And for the patient who never achieves a CR, or for one who converts from a CR/PR to an NR, one has to wonder what is the root cause. Is the cancer simply resistant to our ACT?. Imo, there are just too many other potential variables at play that are unrelated to our ACT's mechanism of action...an MOA that has clearly demonstrated the ability to efficiently destroy cancer cells indiscriminately & regardless of any cellular/genetic variation that may be present within an individual patient. Ultimately, this simpler & more versatile two-dose treatment protocol would give practicing docs more leeway that should not only lead to off-label use, but also bring about ACT modifications/refinements for select cases (I.e. dosing changes, an increase in number of treatments, use of newer generation organometallics from our patented library, IV Rutherrin in combo, etc.)....JMO. Obviously, some non-responders will remain unchanged based on both bladder wall irregularities/variation & provider-dependent reasons (skill level, experience, etc.). Would be interesting to know the NR rate across all facilities when all is said & done...but I guess that's why we hired Vera & our CRO ; ). All imo. Good luck...