Gallium PSMA PET/CT scan - when will this be approved by FDA?

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Prostate Cancer

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teddy9

Regular Member

Joined : Sep 2015

Posts : 188

Posted 5/11/2020 9:10 PM (GMT 0)

Does anyone know when the Gallium based PSMA PET/CT scan results from various clinical trials would be submitted to FDA for approval? Or has it be submitted and we are waiting for approval?

Thanks for any insights

Jerry_Delaware

Regular Member

Joined : Jul 2011

Posts : 248

Posted 5/12/2020 6:17 PM (GMT 0)

Don't know about Gallium Based PET/CT but see this press release in December 2019 for DCFPyL. “Based on these positive results, we plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL in the second half of 2020.”

https://www.biospace.com/article/releases/progenics-pharmaceuticals-announces-phase-3-condor-trial-of-pyl-in-prostate-cancer-achieved-primary-endpoint/

...Jerry

teddy9

Regular Member

Joined : Sep 2015

Posts : 188

Posted 5/12/2020 7:11 PM (GMT 0)

Thanks for posting that link.

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