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Last Updated: 06/09/2016

DCTD’s Cancer Imaging Program Instrumental
in Research Leading to Recent FDA Approval
of PET Imaging Agent for Recurrent
Prostate Cancer

On May 27, 2016 the Food and Drug Administration (FDA) approved Axumin™ (fluciclovine F18) as a positron emission tomography (PET) imaging diagnostic agent for men suspected as having recurrent prostate cancer. Axumin™ targets plasma membrane amino acid transporters (e.g., LAT-1 and ASCT2; Oka, et al, 2012 External Link ), which are often upregulated in recurrent prostate and other cancers. The strength of this targeted, radiolabeled agent is its specific uptake into prostate cancer cells, thus allowing diagnostic imaging of the tumor. FDA approval of this new imaging agent will lead to earlier identification of the location of metastatic deposits in patients who have rising PSA following initial treatment. When the exact location of metastases is known (usually in lymph nodes or in bone), it may be possible to specifically treat them. This agent will also be useful in the future for diagnostic imaging of other cancers, such as glioblastoma, because other tumors are known to have higher expression of these targeted amino acid transporters. The FDA has granted the company marketing Axumin™ orphan drug designation for glioblastoma.

NCI’s Cancer Imaging Program (CIP) in the Division of Cancer Treatment and Diagnosis was instrumental in supporting the early development of Axumin™. CIP’s Development of Clinical Imaging Drugs & Enhancers program performed the initial toxicology studies that enabled academic investigators (Mark Goodman, PhD External Link and David Shuster, MD External Link , both at Emory University) to obtain an IND, and CIP funded grants for early clinical trials (Schuster et al, 2007 External Link ). A trial was also performed at the NCI’s Molecular Imaging Program in the Center for Cancer Research (Turkbey et al, 2014). The agent was subsequently licensed to GE Healthcare and then transferred to Blue Earth Diagnostics External Link who completed the development. NCI continues to provide grant funding to the original investigators to expand the uses of this agent.