FDA Approves Diagnostic Imaging Agent Axumin for Recurrent Prostate Cancer

FDA Approves Diagnostic Imaging Agent Axumin for Recurrent Prostate Cancer
The US Food and Drug Administration (FDA) has recently approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer. Axumin (marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom) is indicated for positron emission tomography (PET) imaging in patients previously treated but who are suspected to have recurrent disease based on elevated levels of the prostate specific antigen (PSA). “Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Dr. Libero Marzella, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research in a recent press release. “Axumin is shown to provide another accurate imaging approach for these patients.” The FDA approval was based on the results of two efficacy and safety clinical trials of Axumin scans in patients with supposed recurrent prostate cancer. In the first trial, 105 Axumin scans were compared with the histopathology samples from prostate biopsy as well as biopsies of suspicious imaged lesions in patients with suspected recurrent disease. In the second trial, the team of researchers examined 96 Axumin
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