Axumin (fluciclovine [18F]), a radioactive diagnostic agent, has been FDA approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.

“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, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Axumin is shown to provide another accurate imaging approach for these patients.”

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The approval of Axumin was based on two studies evaluating the safety and efficacy of its use in imaging prostate cancer patients with recurrent disease.  The first study compared Axumin scans to the histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions.  The second looked at the agreement between Axumin and C11 choline scans in patients with median PSA values of 1.44ng/mL.  Both studies supported Axumin as safe and effective for imaging prostate cancer in men with elevated PSA following prior treatment. Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended.

Axumin should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers during administration. The most commonly reported adverse reactions in patients were injection site pain, redness, and a metallic taste in the mouth.

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