New PET Imaging Agent for Recurrent Prostate Cancer Approved by US FDA

The US Food and Drug Administration (FDA) has approved the first PET imaging molecular imaging agent for use in patients who have suspected recurrent prostate cancer.

The agent is indicated for use in Positron Emission Tomography (PET) imaging, is administered by injection, and can help clinicians identify suspected recurrence of prostate cancer in men. The agent is intended for patients with elevated levels of Prostate Specific Antigen (PSA) in their blood following prior treatment. Primary prostate cancer can be treated successfully, but recurrence can occur in nearly 33% of patients, and is detected by testing the PSA levels in the blood.

Blue Earth Diagnostics (BED; Oxford, UK) licensed the agent, Axumin (fluciclovine F 18), from GE Healthcare (Chalfont St Giles, Buckinghamshire, UK), and is investigating the molecule for other potential cancer indications, such as glioma. The FDA-approval follows two successful clinical studies of Axumin.

Brian F. Chapin, MD, assistant professor, Department of Urology, the University of Texas MD Anderson Cancer Center, said, “Approximately 180,000 new cases of prostate cancer are expected to be diagnosed in the United States in 2016, and between 20 to 30 percent of patients receiving primary therapy will develop biochemically recurrent disease. There is a need for clinical imaging techniques that can detect and localize suspected recurrent prostate cancer to facilitate the most appropriate patient management decision. Current commercially available imaging techniques have some limitations in terms of identifying recurrent tumors, which may impact subsequent patient management decisions. Additionally, many patient care options for men with suspected recurrent prostate cancer have uncertain benefits that may not justify the risk of side effects. New imaging procedures that can provide reliable information can be useful tools for effective patient management and care.”

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Blue Earth Diagnostics
GE Healthcare