由 John R. Fischer
, Senior Reporter | August 08, 2019
Each man received a fluciclovine scan as part of their post-surgical recurrence standard-of-care treatment, and underwent a PSMA scan within 15 days before or after the standard. Images were then read by three physician readers who were unaware of each others’ findings.
The PSMA scan was found to be more accurate in detecting the recurring prostate cancer, locating it in 56 percent of scans. Fluciclovine, in contrast, detected it only in 26 percent of images.
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"Together with a group from UCSF led by Dr. Thomas Hope, we are conducting large scale phase three clinical trials at UCSF to establish the accuracy of PSMA PET/CT imaging in various clinical situations," said Czernin. "These data have been analyzed and will be submitted to the FDA for a New Drug Application (NDA) within the next few weeks. FDA approval is, of course, a prerequisite to establish PSMA imaging as the new standard of care in biochemical recurrence of prostate cancer."
Production of Axumin is carried out by Blue Earth Diagnostics, which has been seeking to increase access to the agent throughout Europe. The company was recently bought by Bracco Imaging, an agreement which is expected to expand the presence of Blue Earth Diagnostics (and perhaps, Axumin) into more than 100 markets. https://www.dotmed.com/news/story/47223 https://www.dotmed.com/news/story/47756
Axumin is currently approved for use in the U.S. and Europe. PSMA PET/CT is investigational and is not FDA approved.
The findings were published in The Lancet Journal
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