On May 27, 2016, the US FDA approved Blue Earth Diagnostics' Axumin, a new radioactive injectable diagnostic agent for positron emission tomography (PET) imaging. Patients with suspected prostate cancer recurrence were examined according to previous treatment of prostate specific antigen (PSA) levels.
Prostate cancer is the second leading cause of cancer death in men in the United States. The precise positioning of the initial patient's treatment recurrence is particularly important for improving the treatment and outcome of the disease.
Libero Marzella, MD, Ph.D., director of imaging at the FDA's Center for Drug Evaluation and Research, pointed out: 'When PSA is very low, imaging tests cannot determine where prostate cancer recurs. Axumin provides patients with another accurate imaging method.
Axumin is a radiopharmaceutical and should be managed by appropriate safety measures. For patients and health care providers, minimize radiation exposure while the image may be in error. A negative image does not rule out the presence of recurrent prostate cancer, and a positive image cannot be confirmed to be a recurrence of prostate cancer. Also consider clinical relevance, including recommendations for investigating pathological evaluation of suspected recurrence points.
The most common adverse reactions were pain, redness, and metallic taste in the mouth of the patient.
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