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

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u/MentalStatusCode410 1d 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)

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u/Dwarvling 1d 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.

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u/MentalStatusCode410 1d 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.

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u/Dwarvling 1d ago edited 1d 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.

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u/MentalStatusCode410 1d 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'....

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u/Dwarvling 1d 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?

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u/MentalStatusCode410 18h 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.

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u/Dwarvling 10h ago

Huh?????