The FDA today approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer.
The agent is indicated for PET imaging in men who have suspected prostate cancer recurrence based on elevated PSA levels following treatment.
The FDA based its decision on results of two studies that evaluated the safety and efficacy of Axumin (Blue Earth Diagnostics). One study compared 105 Axumin scans to histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in men suspected of having prostate cancer recurrence. In the second study, researchers evaluated 96 Axumin scans with C11 choline scans in patients with a median PSA of 1.44 ng/mL.
In both studies, on-site radiologists read the scans, followed by three independent radiologists who read the same scans in a blinded fashion. Overall, results of the independent scan readings were consistent and confirmed the results of the on-site readings, thus supporting the efficacy of Axumin for imaging prostate cancer.
The most common adverse reactions associated with Axumin include injection site pain and redness and a metallic taste in the mouth.
“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, said in a press release. “Axumin is shown to provide another accurate imaging approach for these patients.”