by Gus Iversen
, Editor in Chief | September 06, 2016
Axumin (Fluciclovine F 18), a first-of-its-kind FDA-approved PET imaging agent commercialized by Blue Earth Diagnostics, is now being used at Atlanta's Northside Hospital to image patients with suspected biochemically recurrent prostate cancer.
Biochemically recurrent prostate cancer is suspected when the patient has elevated blood levels of prostate specific antigen following initial treatment. Providers currently have very few imaging tools available for the evaluation of this patient population, according to Dr. William C. Lavely, nuclear medicine specialist at Northside Radiology Associates.
"Our initial experience is positive, demonstrating abnormal uptake in locations of potential metastatic prostate cancer," he said in a statement. "In my opinion, this prostate cancer PET agent, its clinical use for the evaluation of recurrent prostate cancer, and the additional information it provides for developing patient management plans, has the potential to lead to better outcomes in men with recurrent prostate cancer."
Still, Lavely said further studies are necessary to determine these potential benefits.
Axumin is commercially manufactured and distributed in the U.S. exclusively by Siemens' PETNET Solutions
, and production is underway at certain regional radiopharmacies with expanded availability expected in the coming months.
“Blue Earth was formed and licensed fluciclovine in 2014, and it is extremely rewarding that our development efforts and FDA’s Priority Review and approval have made Axumin available for these patients in a brief period of time," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. "Axumin is now being commercially administered in other medical centers, in addition to Northside Hospital, and we anticipate that more patients will be able to receive Axumin as commercial availability expands.”