FDA Approves Gallium 68 PSMA PET Scan

FDA Approves Gallium 68 PSMA PET Scan Today 

But Only at UCLA (Los Angeles) and UCSF (San Francisco)

NOT Generally Available yet….Hang Tight for Developing News

 

The FDA approved the Gallium 68 PSAM PET Scan for prostate cancer patients today.  Two types of patients are listed as eligible:

·       Newly Diagnosed (“Initial Staging”) at risk for metastatic disease BEFORE definitive therapy (surgery, radiation, etc.)

·       PSA Recurrence AFTER definitive therapy (surgery, radiation, etc)

The Prostate Cancer Foundation states that “68Ga-PSMA-11 PET scanning will be available at only UCLA and UCSF. Radiopharmaceutical companies will likely apply for expedited FDA approval to make 68GaPSMA-11 “kits” so that this technique will eventually be available to more patients throughout the US.”
Here’s what we know today about the Gallium PSMA PET Scan:

·       It may be FDA-approved, but it is NOT generally available to prostate cancer patients yet.  Please watch UCLA or UCSF websites and press release as new develops.  Also watch Cancer ABCs for developing news.   

·       This is NOT the same AS PSMA PET (18F-DCFPyL) by Progenics/Lantheus, which is currently in the pipeline, with expected FDA ruling in the 2nd half of 2021.

·        This Gallium 68 PSMA PET Scan will have a new name soon – watch for this news, which can be a little confusing.

·       This is NOT a treatment for prostate cancer.  It is a radio-pharmaceutical injection (like all other PET Scans, including Axumin), But it is classified as a drug by the FDA.  It is an injection for imaging.

Here is a short VIDEO by Dr Thomas Hope at UCSF, the Principal Investigator for the Gallium 68 PSMA PET Scan trials.