The U.S. Food and Drug Administration (FDA) has accepted molecular imaging firm Blue Earth Diagnostics' supplemental new drug application for the use of its Axumin (fluciclovine F-18) PET radiopharmaceutical in brain cancer detection.
This filing acceptance follows a recent phase III trial (BED006) that reported superior results in glioma diagnosis when using fluciclovine F-18 PET and MRI, compared with MRI alone. The radiopharmaceutical previously received FDA approval for the detection of prostate cancer.
