Third PSMA PET indicator may be approved by FDA

[Tall_Allen]

F18-rhPSMA-7, is an experimental PET indicators that is cleared quickly from the bladder, and is among the best so far. In a clinical trial, it was able to find prostate cancer metastases in 71% of men with post-prostatectomy PSA between 0.2-0.5 ng/ml, which is about 50% greater than the detection rate of the two currently approved PSMA PET indicators. See chart at end of this article:

prostatecancer.news/2016/12...

The rapid bladder clearance means it will not be as subject to false positives in and around the prostate.

Here's the announcement. The FDA usually takes many months to grant approval, but it may be faster because there are already two indicators in this category. I expect that a fourth PSMA PET radioindicator (18F-PSMA-1007) will eventually come up for approval also.

businesswire.com/news/home/...

All of the PSMA PET radioindicators have been tested in newly diagnosed patients (high risk and metastatic) and will be approved for those indications as well.

[RJAMSG]

Looks promising thanks for sharing this update!

[Nusch]

Thank you TA and enjoy your day!

[Schwah]

in your opinion is it better than any of the existing scans by enough of a degree to fight to get it?

Schwah

[Tall_Allen in reply to Schwah]

It's not approved yet - you can't get it.

[Schwah in reply to Tall_Allen]

no put of pocket possibilities like I did on the PSMA scan before it was approved ?

[Tall_Allen in reply to Schwah]

You were able to get it because UCLA was running a trial.

[Schwah in reply to Tall_Allen]

gotcha….thank you !

[Manilo in reply to Schwah]

In Spain and Argentina it is being used already

[NOTaQUITTER]

When might these new scans be approved for use in diagnostic screening for PCa patients that have not been treated via RP or Radiation? Any insights on this front are appreciated.

[meowlicious99 in reply to NOTaQUITTER]

Looks like its inferior in those patients according to the TA's link

jnm.snmjournals.org/content...

Perhaps i missed something , Why would RP/Radiation patients want this scan though ?

[Tall_Allen in reply to meowlicious99]

That link has nothing to do with this.

[meowlicious99 in reply to Tall_Allen]

sorry TA. I missed the word 'not' in GP's post.

[Tall_Allen in reply to NOTaQUITTER]

I have no idea.

[slpdvmmd]

Will be interesting to see what cms and insurance does with this. My understanding is that some insurers are already saying no to Lu177 after pylarify scan and saying they only accept Gallium based scan.

[Tall_Allen in reply to slpdvmmd]

Appeal based on NCCN guidelines.