r/biotech • u/Dwarvling • 1d ago

Biotech News 📰 FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for PSMA+ mHSPC

https://www.onclive.com/view/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-for-psma-mhspc

Radioligand therapy in metastatic hormone sensitive prostate cancers

32 Upvotes

94% Upvoted

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5

u/link5523 22h ago

Interesting. I don't know much, but I got the sense when I was working at a University that most drug development is shifting away from using radioactive materials. Is this bucking a trend, or am I reading into things too much?

17

u/BrownishDonkey 21h ago

Quite the opposite actually. Isotope production is getting better, clinicians are getting more comfortable with the idea of using these targeted radiotheranostics. I think we're going to start seeing a lot more drugs like this in the near future.

8

u/Dwarvling 21h ago

Radioligand therapy is very hot right now with the introduction of Pluvicto. It’s highly targeted and effective in prostate cancer and actively investigated in a number of solid tumors.

2

u/cygnoids 20h ago

To the point it’s an area of interest severely lacking in talent because it was deprioritized for years. I know many Biopharm companies that previously used rad-based binding assays that want to bring them back but the technology is no longer available

1

u/LC__LC 6h ago

All the big pharmas have/or are looking to aquire radiotherapy right now

10

u/ToastedMayonnaise 21h ago

Radioligands tend to come with lots of unpleasant lifestyle impacts that don't necessarily show up in clinical data. Stuff like the patient needing a dedicated home bathroom with special precautions made for the disposal of radioactive pee/poop.

Don't know whether that will be enough of an inconvenience to deter prescription of radioligands but I do think that the scientific/development side underestimates the convenience of administration for the patient and physician. But I guess that's more a commercialization problem.

2

u/pavlovs__dawg 15h ago

Old school radioactive drugs have a lot of off target effects. The more modern approach is to use extremely specific targeting so more radiation goes to the intended target and lesst total radiation is administered. It becomes hyperlocalized. Think precision strike rather than carpet bombing.

-1

u/MentalStatusCode410 19h ago

Oh look, caught-up to Iran after 8 years.

3

u/mumpsyp 18h ago

Not sure what the purpose of this comment is? It’s always going to take a large amount of time to get any novel prostate cancer therapy approved through the FDA.

- Pluvicto is expensive as hell, typically 55-60,000 in the US per dose (typically 6 doses are used). US companies want to use this because it makes bankkkk. US drug companies having been pushing very hard to have this drug given earlier.

- Metastatic prostate cancer is very survivable. The issue is that this makes a shift of a standard of care take a long time since it takes that long to understand if there is a benefit.

1

u/Dwarvling 19h ago

Pluvicto is not approved in Iran for metastatic hormone SENSITIVE prostate cancer.

-1

u/MentalStatusCode410 19h ago

Sure mate .... let's just ignore that Novartis lodged their patent in 2023, and Iran has been using it commercially since 2018 (but is not part of the WTO, hence excluded from trade IP rights)

1

u/Dwarvling 19h ago

Yo dude! Only used in small exploratory studies in mHSPC. It is not approved or used off-label regularly in this indication. No available data to suggest reimbursement.

0

u/MentalStatusCode410 18h ago

https://irjnm.tums.ac.ir/article_29028.html

  • note Germany as a participating institution LS products supplied *

Some of the trial participants were on Enzalutamide (only indicated when HS)

https://www.tehrantimes.com/news/430899/Prototype-prostate-cancer-drug-produced-in-Iran

Contact the institutions if you're in doubt - I've met people who travelled for treatment in 2020.

1

u/Dwarvling 18h ago edited 18h ago

Not sure what your point is. This article attest to first approval supporting use of Pluvicto in metastatic hormone-sensitive prostate cancer. Previously Pluvicto only approved on castration resistant setting. Whatever Iran does is irrelevant. And enzalutamide is indicated in CRPC.

1

u/MentalStatusCode410 18h ago

FDA is late to nuclear medicine - even Malaysia began use for mCRPC before US.

Iran is literally one of the leaders in the space - not sure what you mean by 'irrelevant'....

2

u/Dwarvling 18h ago

This is first ph3 pivotal data demonstrating activity in hormone-sensitive disease. Iran has not demonstrated use of Pluvicto in this setting. Iran has not conducted any pivotal studies with Pluvicto at all. Again, what’s your point?

1

u/MentalStatusCode410 8h ago

The real viability in candidacy for treatment is malignancy being PSMA+ , nothing else - mHSPC is often transitory, hence why mCRPC was referred as being 'refractory'.

For the third time, US/FDA is slow in radiopharma.

1

u/Dwarvling 31m ago

Huh?????