FDA Approves New Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer


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On May 27, the U.S. Food and Drug Administration (FDA) approved fluciclovine F-18 (Axumin), a radioactive diagnostic agent for injection. Fluciclovine F-18 is indicated 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, MD, PhD, Director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “[Fluciclovine F-18] is shown to provide another accurate imaging approach for these patients.”

Study Results

Two studies evaluated the safety and efficacy of fluciclovine F-18 for imaging prostate cancer in patients with recurrent disease. The first compared 105 fluciclovine F-18 scans in men with suspected recurrence of prostate cancer to the histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions. Radiologists onsite read the scans initially; subsequently, three independent radiologists read the same scans in a blinded study.

The second study evaluated the agreement between 96 fluciclovine F-18 and choline C-11 scans in patients with median PSA values of 1.44 ng/mL. Radiologists onsite read the scans, and the same three independent radiologists who read the scans in the first study read the fluciclovine F-18 scans in this second blinded study. The results of the independent scan readings were generally consistent with one another, and confirmed the results of the onsite scan readings.

Both studies supported the safety and efficacy of fluciclovine F-18 for imaging prostate cancer in men with elevated PSA levels following prior treatment.

Fluciclovine F-18 is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure. The most commonly reported adverse reactions in patients are injection site pain, redness, and a metallic taste in the mouth. ■



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