The National Comprehensive Cancer Network (NCCN) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) have now updated their guidelines to allow use of Pylarify PSMA PET to qualify for Pluvicto (177Lu-PSMA617).
As you may know, the FDA only approved 68Ga-PSMA-11 PET to qualify for Pluvicto. That's because the FDA can only approve what was used in the VISION trial. But Pylarify is more widely available. Insurance companies and Medicare may still deny Pluvicto if there is only a Pylarify scan, but they will probably reverse their decision with the new NCCN guideline.
Novartis is still 6 weeks off from supplying Pluvicto.
Written by
Tall_Allen
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Thank you TA. I think I read that pluvicto is not being manufactured in the US because of some quality issues - do you know anything about that, and when they may start again?
That’s so exciting. Five years ago, I was one of the early folks who were newly diagnosed for whom insurance would cover abiraterone while still castrate sensitive. One day, I suspect I’ll need a next option so this is wonderful. Thanks, TA! ✌️ DougNOLA
@cesces Basically you can't use the Pluvicto treatment until you can see the cancer on a PSMA PET Scan because the Pylarify "tracer" drug they inject in you binds to PSMA. If nothing shows up on the scan, it doesn't mean you don't necessarily have active cancer, it's just not large enough to see on the scan. The Pluvicto binds to the cancer the same way as the Pylarify does. So there's nothing (or very little) for the Pluvicto to bind to if there's nothing on the Pylarify PSMA PET Scan. The good news is Pylarify is a little more sensitive than the older Ga68 PSMA so patients might be able to get the Pluvicto treatment a little earlier now.
@Tall_Bill Really appreciate all you do to keep people up to date. Hopefully Radioligand treatments like Pluvicto will be improved in the coming years as to date, it seems it significantly helps with impeding progression of distant metastases but unfortunately if I recall the time to cancer mortality was lengthened by an average of only 4 months. I believe the trial though was limited to people at a very late stage though? It seems like Radioligand and Immunotherapy are the areas we can look forward to further advancements and hopefully one day either there will be a cure, or, the disease can be managed indefinitely like HIV. The latter may come sooner than we might expect. I am anxious to see results from further trials where treatments like Pluvicto are used at the very first sign of PSMA PET detected recurrence.
Good post and clear views jazj. I am getting a novel form of Lu PSMA monoclonal antibody radioligand treatment tomorrow morning here in Perth where I flew yesterday to receive this. It is not in a trial. It is unproven and pre-trial as I am HSPC oligometastatic with all identified sites already treated with SBRT a month ago. Why am I doing this? I am preparing a post for later tonight to address that very question . I will be interesting your take. Regards. MateoBeach
Read your post. I would do exactly the same thing in your situation. Takes some courage! But you could provide extremely valuable information on how patients responds doing Radioligand treatment earlier than later.
The splash clinical trial, is using a competitor's similar product for PSMA therapy with reportably less side effects to saliva glands, kidneys.Over a year behind, but a competitor may help keep prices down, and avoid supply issues.
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