Another Lu-177 solution gets fast tra... - Advanced Prostate...

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Another Lu-177 solution gets fast tracked: Lu-177-DGUL, secures 'GIFT' designation

Maxone73 profile image
11 Replies

"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?

koreabiomed.com/news/articl...

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Maxone73
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11 Replies
Izzygirl1 profile image
Izzygirl1

This is good news! Thanks for sharing it!

Peppertree602 profile image
Peppertree602

from what I read this is on Korea and possibly Asia

How long before the US any guess?

Maxone73 profile image
Maxone73 in reply toPeppertree602

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.

Epikos profile image
Epikos

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?

Maxone73 profile image
Maxone73 in reply toEpikos

Hello! I cannot answer that question as the drug will be released to the market within the next 6 months in South Korea, so they are recruiting there:

clinicaltrials.gov/study/NC...

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"

Epikos profile image
Epikos in reply toMaxone73

Thank you for the info.

APK3 profile image
APK3

Thank you 73 for staying on top of things. It is appreciated.

MateoBeach profile image
MateoBeach

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.

Maxone73 profile image
Maxone73 in reply toMateoBeach

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.

Leader4077 profile image
Leader4077 in reply toMaxone73

Is South Korea recruiting patients from other countries. Can this version of Lu-177 be paid for privately?

Maxone73 profile image
Maxone73 in reply toLeader4077

Normally trials enroll people from other countries providing that you pay for your stay but you should contact them directly

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