Lu177 Phase 3 to FDA approval - how long usually

It seems like the clinical trial for phase 3 has already started. I saw a video of it and it is a miracle drug. My best friend has just started treatment on Firmagon and may possibly have Zytiga added if his liver enzymes do not show increased level. Just thinking ahead if , by chance, Firmagon doesn't work for him anymore, would Lu177 be FDA approved or not . He has medicare and Tricare ( the best plan available).

Also, I have been reading hours educating myself on advanced prostate cancer and noticed that no one has the combination of firmagon and Zytiga but would have Lupron and Zytiga combination instead. Is there a reason?

Is Lupron and Zytiga way better than firmagon and Zytiga combination?

Thanks so much everyone . I am glad that I found this site.

[Tall_Allen]

Probably little difference over time between Firmagon and Lupron. Lupron is more convenient because one can get 3,4, or 6-month shots.

The Phase 3 trial of Lu-177-PSMA-617 is currently scheduled for completion by August 2020, so their analysis will be reported a few months later. And if it safe and beneficial, FDA approval would probably be fast-tracked to early in 2021. It is currently at 14 locations, and they expect to double that, so it should meet recruiting goals quickly.

[Fairwind in reply to Tall_Allen]

I could only find one closed phase 2 trial...I must be looking in the wrong place...Whoops ! I found all the trials, used the advanced search, leave the country and city blank..Now that Novaris has jumped in for $2 Billion, we can expect more locations to open and pressure to fast-track this..

[Tall_Allen in reply to Fairwind]

clinicaltrials.gov/ct2/show...

They plan to have around 30 locations

Fast-track depends on FDA's assessment

[Fairwind]

Here is why new treatments like Lu-177-PSMA-617 end up costing so much..

evaluate.com/vantage/articl...

[ARIES29 in reply to Fairwind]

What a pity human greed has to be involved with the treatment of this incidious desease