RE:RE:RE:J and J Tar 200 claiming a high CR % for NMIBCThere is also the safety issue to consider. They reported that
9.4% of the 85 patients (8 patients} experienced a
treatment related adverse event greater than grade 3, and
5 of these patients (6%) were removed from the trial as a direct result of the severity of their adverse reaction to the treatment. As a comparison,
there is a 0% incidence of serious adverse events directly related to Ruvidar PDT.
Intravesical system for prolonged delivery of gemcitabine improves outcomes in two forms of bladder cancer I suppose the discontinuation rate should not come as too big a surprise considering how many times they have to implant and then remove the
TAR-200 device from the bladder -
10 times in the first year. Gemcitabine, the drug delivered by the
TAR-200 device, when administered intravesically without the
timed release provided by TAR-200, is only marginally more effective than saline solution, if at all..
Intravesical gemcitabine for nonmuscle invasive bladder cancer DJDawg wrote: Compared to the original post above, there is more recent data
TAR-200 monotherapy provides complete response rate of 84% in patients with BCG-unresponsive high-risk NMIBC, based on published data, without the need for re-induction
By 12 months the estimated CR is down to 57.4% which is still good but keep in mind that this after a first year in which they are being treated every 3 weeks until 8 months are completed. After that they go to an every 3 month treatment. So I'm assuming that the FDA is going want to know what the 450 day and longer data is like as if it tails off further.
Remember adstiladrin fell off bigtime between 12 and 24 months.