FDA Approves Agent that Detects Recurrent Prostate Cancer

The FDA has approved fluciclovine F 18 (Axumin), which is a radioactive diagnostic agent for injection that can be used to detect recurring prostate cancer.

If a male patient shows signs of elevated prostate specific antigen (PSA) levels, he may benefit from using Axium for positron emission tomography.

“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, explained in a press release. “Axumin is shown to provide another accurate imaging approach for these patients.”

In one study, 105 Axumin scans were taken in men who were suspected to have recurrent disease, and investigators compared the scans with histopathology taken by prostate biopsy and by biopsies of suspicious imaged lesions. Onsite radiologists and 3 independent radiologists read the same scans in a blinded study.

In a second study, the investigators found that independent scan readings were consisted with each other, and the onsite scan reading results were confirmed.

Both studies demonstrated that Axumin for imaging prostate cancer in men with high PSA levels following prior treatment was safe and effective.

However, since Axumin is a radioactive drug, health care professionals should be careful about minimizing radiation exposure.

The most common adverse effects in patients who received Axumin were pain at the injection site, a metallic taste in the mouth, and redness.

Prostate cancer is the second leading cause of death from cancer among men.