On May 27, 2016, the FDA approved fluciclovine F18 (Axumin; Blue Earth Diagnostics) injection, a radioactive diagnostic imaging agent used to detect recurrent prostate cancer.
Fluciclovine F18 injection is indicated for use with positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels.
“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, MD, PhD, Director of the FDA’s Center for Drug Evaluation and Research Division of Medical Imaging Products. “Axumin is shown to provide another accurate imaging approach for these patients.”
The FDA approval was based on 2 blinded studies evaluating the safety and efficacy of fluciclovine F18 injection. The first study compared 105 scans using fluciclovine F18 injection with histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in patients with suspected recurrence of prostate cancer. The second study compared the results from 96 scans using fluciclovine F18 injection with C11 choline scans, an approved PET scan imaging test, in men with a median PSA value of 1.44 ng/mL.
In both studies, onsite radiologists and 3 independent radiologists read the scans, and their conclusions were generally consistent with one another.
The most frequently reported adverse events were injection site pain, redness, and a metallic taste in the mouth.
Because fluciclovine F18 is a radioactive drug, the FDA recommends appropriate safety measures to limit exposure to patients and providers during administration.