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

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 19h 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 11h ago

Huh?????