FDA approves Emory-developed prostate cancer imaging probe (FACBC/Axumin)

A cancer imaging agent that was originally developed at Emory University was approved on Friday, May 27 by the U.S. Food and Drug Administration. Axumin, a PET (positron emission tomography) imaging agent, is indicated for diagnosis of recurrent prostate cancer in men who have elevated blood levels of prostate specific antigen (PSA) after previous treatment. Axumin, now being commercialized by UK-based Blue Earth Diagnostics, is also known as 18F-fluciclovine or FACBC (an abbreviation for anti-1-amino-3-[18F]fluorocyclobutane-1- carboxylic acid). Imaging using axumin is expected to help doctors detect and localize recurrent prostate cancer, and could guide biopsy or the planning of additional treatment, says David Schuster, MD, director of the Division of Nuclear Medicine and Molecular Imaging and associate professor of radiology and imaging sciences at Emory University School of Medicine and Winship Cancer Institute. Fluciclovine was originally developed by Mark Goodman, PhD, professor of radiology and imaging sciences at Emory University School of Medicine and Winship Cancer Institute, and Emory Endowed Chair of Imaging Sciences, along with Timothy Shoup, PhD, now at Massachusetts General Hospital. Baowei Fei, PhD, EngD, is researching how to combine fluciclovine with ultrasound to guide prostate biopsy. Fei is associate professor of radiology and imaging sciences, a Georgia Research Alliance Distinguished Cancer Scientist, and part of the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory.

For more information about this news, please visit: http://news.emory.edu/stories/2016/06/fluciclovine_fda_approval/

For more information about the targeted biopsy study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02744534/