December 10, 2018 -- BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.

Fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging to visualize the increased amino acid transport that occurs in malignant tumors such as glioma, which is a serious and life-threatening condition accounting for about 80% of all malignant brain tumors.

18F-Fluciclovine, under the tradename Axumin® (fluciclovine F 18) injection, is FDA-approved for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. 18F-Fluciclovine PET imaging is being investigated for the detection and continuing assessment of glioma. (For additional product information please see the end of this news release.) 18F-Fluciclovine has previously been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma.
"We are very pleased that the FDA has accepted for review our sNDA submission for the use of 18F-fluciclovine PET imaging in glioma," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Expanding the label for Axumin is part of our mission to develop and commercialize innovative PET imaging products that address unmet medical needs for patients with cancer."

"Glioma is the twelfth leading cause of death from cancer, and certain aggressive forms of the disease, such as glioblastoma multiforme, can progress rapidly," said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. "Physicians need precise information about the location and extent of the tumor to help guide surgical procedures and radiation therapy, as well as for subsequent continued assessment and monitoring of the disease. We are exploring the potential utility of 18F-fluciclovine PET to assist them in these efforts."

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. Results indicated a Positive Predictive Value (PPV) of more than 90% for each of the three blinded readers and consistent image interpretation across these readers. In addition, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that MRI alone was unable to identify, which subsequent biopsies confirmed as malignant. To date, the safety profile of 18F-fluciclovine PET imaging in patients with glioma appears to be consistent with that summarized in the current Axumin U.S. prescribing information.

Molecular Imaging Homepage