"On Monday, the Ministry of Food and Drug Safety (MFDS) designated Lu-177-DGUL as the 11th agent to benefit from its “Global Innovative Products on Fast Track” (GIFT) program, signifying a significant milestone in the quest to offer a beacon of hope for prostate cancer patients who currently have limited viable treatment options."
Maybe there's a chance to get into some trial for some of our warriors?
Guesstimation: if everything goes smoothly and no "war" from other companies, getting Fast Track, Priority Review, Breakthrough Therapy Designation, Accelerated Approval and every other applicable advantage they can give to a life-saving treatment....6 to 10 months. Worst case scenario....they will have to repeat the whole phase 1, 2 and 3. But that would be real bad bad luck
Of course they are supposed to launch in first half of 2024, so that mean we could need to add 6 months to the best case scenario.
If one had Pluvicto treatment already, would this be an option? My husband’s PSA dropped considerably with the first 3 treatments of Pluvicto and then rose steadily with the last 3 treatments. Would this new version of LU-177 be an option?
Pluvicto would exclude him from the trial for 6 months after the last dose:
"Those who had previously received PSMA-targeted treatment or received radiopharmaceutical treatment, such as radium-223, within 6 months prior to baseline"
From what I can piece together Lu-DGUL has "the same binding characteristics as Pluvicto" (Lu-PSMA-617) and the elimination route is also primarily via kidneys/urinary excretion as does Pluvicto. So any significant advantage remains to be seen beyond thePhase 1/2 trial. I would still bet on a monoclonal antibody ligand such as J591 or others being developed with either Lu177 or Ac225 or other newer isotopes in the pipeline.
We will know soon. But the amount of responses on patients seems to be better that the % of response to Pluvicto if I remember correctly. 80% is a quite good.
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