FDA Approves New PET Imaging Agent for Recurrent Prostate Cancer

Today Blue Earth Diagnostics announced that the FDA has approved AxuminTM (F-18-labeled fluciclovine injection) for detecting biochemical recurrence of prostate cancer. It is the first FDA-approved F-18-labeled PET imaging agent for use in patients with suspected recurrent prostate cancer.

Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients. In some patients, recurrent disease is detectable only by a rise in prostate-specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, severely limiting treatment guidance for these patients.

Axumin is a novel PET imaging agent for use in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. PET imaging with the new agent may identify the location and extent of such recurrence. The agent was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer.

“Finding disease in men who have been treated for primary prostate cancer but present with a rising PSA has been a significant unmet need in medicine,” said SNMMI President Hossein Jadvar, MD, PhD, MPH, MBA, FACNM. “We are excited to see that FDA has approved an agent that can facilitate the imaging evaluation of this large cohort of men with biochemical recurrence of prostate cancer. SNMMI has appreciated working with the FDA on bringing new molecular imaging drugs to approval. We applaud the FDA for recognizing the importance of this advanced imaging agent and granting priority review status.”

The FDA-approved prescribing information provides summaries from two clinical studies of Axumin, including an evaluation of images from 105 patients by three independent readers who were unaware of the clinical details of each patient or whether the biopsy of the prostate gland was positive or negative for cancer.

“An imaging agent with sufficient diagnostic performance to adequately detect and localize recurrent prostate cancer can provide referring physicians with actionable information to guide biopsy and inform management decisions for their patients,” said David M. Schuster, MD, associate professor of Radiology and Imaging Sciences and director of the Division of Nuclear Medicine and Molecular Imaging at Emory University School of Medicine. “The fluciclovine molecule in Axumin was originally developed at Emory by Mark Goodman, PhD, and detects the upregulation of amino acid transport that occurs in prostate cancer and can potentially identify recurrent prostate cancer more reliably than conventional imaging techniques. The product will be convenient for patients and imaging facilities, as it can be made widely available and the entire imaging procedure can typically be completed in less than 30 minutes.”

Axumin will be commercially available through the national radiopharmacy network of Blue Earth Diagnostics’ exclusive U.S. commercial manufacturer and distributor, Siemens’ PETNET Solutions. Initial commercial production of Axumin is underway at certain regional radiopharmacies, and increasingly broader availability is planned in coming months.

Society of Nuclear Medicine and Molecular Imaging