FDA approves Emory-developed cancer imaging probe

A cancer imaging agent that was originally developed at Emory 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 PSA levels 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).

goodman-schuster

Mark Goodman, PhD (left) and David Schuster, MD (right)

Imaging using axumin/fluciclovine is expected to help doctors detect and localize recurrent prostate cancer, and could guide biopsy or the planning of additional treatment. Fluciclovine was originally developed at Emory by Mark Goodman and Timothy Shoup, who is now at Massachusetts General Hospital.

The earliest research on fluciclovine in the 1990s was on its use for imaging brain tumors, and it received a FDA “orphan drug” designation for the diagnosis of glioma in 2015. About a decade ago, Emory researchers stumbled upon fluciclovine’s utility with prostate cancer, while investigating its activity in a patient who appeared to have renal cancer, according to radiologist David Schuster, who has led several clinical studies testing fluciclovine.

“This led us to see if this radiotracer would be good for looking at prostate cancer, specifically because of its low native urinary excretion,” Schuster is quoted as saying in the radiology newsletter Aunt Minnie. “If you look at the history of medical science, it is taking advantage of the unexpected.”

Early research on the probe was supported by Nihon Mediphysics, and later support for clinical research on FACBC/fluciclovine came from the National Cancer Institute, the Georgia Research Alliance and the Georgia Cancer Coalition. [Both Emory and Goodman are eligible to receive royalties from its commercialization]. Additional information here.

References for two completed studies on fluciclovine in recurrent prostate cancer

Odewole OA et al. Comparison with CT imaging (2016) 

Schuster DM et al. Head to head comparison with ProstaScint (2014).

FDA approval was based in part on this information, compiled by Blue Earth Diagnostics:

Axumin images from 105 patients were evaluated by three independent readers who were unaware of the clinical details of each patient or whether the biopsy of the prostate gland was positive or negative for cancer. On average, a correct image finding was identified in 77 percent of patients. For cancer outside the region of the prostate, a correct image finding for cancer was identified in an average of 90 percent of patients. The results seem to be affected by PSA levels with, in general, lower PSA levels in patients with negative scans than in those with positive scans. In patients with PSA levels ≤ 1.78 ng/mL, 15 of 25 had a positive scan, with 11 confirmed as positive by histology; 71 of 74 patients with PSA levels > 1.78 ng/mL had a positive scan, of which 58 were confirmed as positive.

Ongoing studies

Schuster and radiation oncologist Ashesh Jani are investigating fluciclovine’s use in recurrent prostate cancer to guide decisions about radiation treatment, in a National Cancer Institute-sponsored clinical trial. Radiologist Baowei Fei is researching how to combine fluciclovine with ultrasound to guide prostate biopsy. Urologist Martin Sanda and colleagues are investigating the use of FACBC/fluciclovine to assess cancer severity in high risk prostate cancer as part of a NIH-supported Prostate Cancer Biomarker Center grant.

Fluciclovine is also being tested as an imaging probe for other types of cancer, such as breast cancer.

FDA News Release

Blue Earth Diagnostics News Release

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Posted on by Quinn Eastman in Cancer Leave a comment

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Quinn Eastman

Science Writer, Research Communications qeastma@emory.edu 404-727-7829 Office

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