Fluciclovine (18F) is being investigated for Positron Emission Tomography (PET) imaging of various cancers. It has been evaluated most extensively for disease localisation in prostate cancer patients with suspected biochemical recurrence.
BED filed for marketing approval with both the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) in 2015, based on studies conducted in the USA, Italy and Norway, on over 700 subjects. The product was approved by the U.S. FDA in May 2016 for use in PET imaging of biochemically recurrent prostate cancer.
Additionally, BED has obtained Orphan Drug designation from EMA and FDA for use of fluciclovine (18F) in glioma. The company anticipates development of follow-on indications in this and other tumor types, as well as other applications in prostate cancer.