Blue Earth Diagnostics announces U.S. FDA filing acceptance of supplemental new drug application for 18F-fluciclovine PET Imaging in Glioma

Blue Earth Diagnostics

10 December 2018 - The application seeks to expand Axumin (fluciclovine F 18) label for use in detection and continuing assessment in adults with glioma.

Blue Earth Diagnostics today announced that the U.S. FDA has accepted for review a supplemental new drug application for the expanded use of Axumin (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.

Blue Earth Diagnostics recently announced results from one of the Phase 3 clinical trials supporting the sNDA submission to the FDA at the Society for Neuro-Oncology annual meeting in November 2018. The study, BED006, was a prospective, blinded image evaluation that examined the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with various types of MRI, for imaging of suspected glioma when interpreted by readers unfamiliar with 18F-fluciclovine PET.

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Michael Wonder

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Michael Wonder

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US , Dossier , Diagnostic agent