Novartis has announced 177Lu-PSMA-617 met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer.
Details will be presented at a medical conference. We will have to wait to find out by how much. FDA approval expected this year.
Great news. Do you expect that it will be approved only for patients who have had prior docetaxel?
Yes, certainly - prior chemo AND either Zytiga or Xtandi. The FDA can only approve indications that were tested.
Maybe I'm misunderstanding. Will you have to have had prior chemo to receive Lu-177 or any of them chemo ,Zytiga, Xtandi?
Chemo AND either Zytiga or Xtandi.
Thank you sir.
Would you still be eligible if you had both Xtandi AND Zytiga in addition to Docetaxel? Fingers and toes crossed for my Dad!
I am tentatively approved for the latest splash trial for lu-177 starting in Omaha Nebraska. Don’t think that with my PSA Rising as it is that I should wait for FDA approval so I’m hoping it all works out. Scheduled to see Dr Luke on April 6th with PSMA scan 2 days later.John
Rah rah rah go Omaha! I’m praying for some healing for great John!🙏
I think the approval will be finalized end of this year or beginning of next year. You cannot wait for that.
Good for you! Dr. Luke is great.
Maybe we will bump in to you. Dr. Luke is starting my husband on a novel cocktail of Avastin+ Opdivo + Cisplatin as he had to drop out of the actinium trial due to complications with his lungs and hemoglobin. We will be traveling to Omaha every three weeks. Praying my husband’s cocktail and your clinical trial will yield great results.🙏 During your downtime, take a drive to Kansas City. Be sure to check out the Country Club Plaza, the Nelson art Gallery, the Crossroads Art District, and a plethora of fabulous barbecue restaurants. Our personal faves are Q39, Joe’s, and Slap’s. If you are a clothes horse, Halls at Crown Center has been reimagined and is luxuriously awesome. We wish you great success!
A recent Phase II study showed superiority to cabazitaxel in PSA response and side effects (sciencedirect.com/science/a.... Looking forward to Phase III publication.
Thanks TA for the info. When will it be available???
You mean the results? Idk. The ASCO meeting is June 4-8 - maybe they will present their findings there.
Thanks TA - I am in the middle of 6 Docetaxel infusions. First 2 have been pretty tough. Looks like I might be a candidate. Good news - PSA and ALP are coming down.
Great news!
Are you aware of any potential sites in Tampa or Chicago area that might have a program for this?
I would assume that all sites that participated in the trial will have it eventually
🤞🏻🤞🏻🤞🏻
Thank you for posting. Looking forward to the findings. We all need to hear something positive.
This is just what I needed to see.
great
That is great. I'm not there yet and hope for much longer on Zytiga but this is hope for beyond Zytiga. I will be on the look out for more information as it is revealed.
Thank you!
That's reassuring, I'm about to enter the ARROW Phase 2 study using I-131-1095. Iodine-131 is a higher energy beta-particle emitter than LU-177 so it can penetrate greater distances through tissue — up to 3.6 mm, compared to 1.9 mm for Lu-177
My Doctor said there already get ready for lu 177 this year .can anyone
Share some of their experiences and does anybody have some wonderful responses that would encourage great John good luck greatjohn
When do you anticipate that this treatment will be available to the general public (i.e., APC patients) after FDA approval? It’s my understanding that a very limited number of places currently do PSMA testing, which is required prior to treatment. Do you expect more widespread availability of PSMA testing following FDA approval of lu 177? Do you have to be castrate resistant to qualify for treatment? How long after FDA approval would you expect insurance/Medicare to cover this treatment? Thanks for any insight that you can provide.
The FDA will probably soon approve DCFPyL PET scans, which will be more widely available. Lu-177-PSMA-617 is on fast track, so maybe by the end of the year? That is what Novartis expects. Medicare covers Lutathera, so I expect they will cover it too. It is only for mCRPC after chemo AND either Xtandi or Zytiga.
Thanks TA.
Question for you Tall-Allen please. You posted an article about nutraceuticals such as antioxidants that would impact the effectiveness of lutetium. I’m sorry but I’ve looked all over this site and I cannot find that article. Can you please direct me to the article. I appreciate you sir!
I'm not sure which article you mean, but antioxidants should be avoided during any kind of radiation therapy. They may interfere with what the radiation is trying to achieve. I don't think this is at all controversial. There are other supplements that should specifically be avoided with PSMA theranostics because they may de-chelate the ligand. To be safe, just avoid any supplements during the therapy. You can resume it afterwards if you believe it does something. That's discussed at the end of this article:
prostatecancer.news/2021/01...
Thank you
Opinions on Lu-PSMA-617 Clinical Trial
Discussion of Phase 2 trial with LU-177 PSMA-617
Lu-177 \"Vision\" trial NCT03511664 Protocols 
VISION Trial Results Being Released
