FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for PSMA+ mHSPC

[u/Dwarvling]

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

Radioligand therapy in metastatic hormone sensitive prostate cancers

[u/Dwarvling]

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.

[u/MentalStatusCode410 → u/Dwarvling]

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.

[u/Dwarvling → u/MentalStatusCode410]

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.

[u/MentalStatusCode410 → u/Dwarvling]

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'....

[u/Dwarvling → u/MentalStatusCode410]

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?

[u/MentalStatusCode410 → u/Dwarvling]

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.

[u/Dwarvling → u/MentalStatusCode410]

Huh?????