FDA approves new diagnostic imaging agent for recurrent prostate cancer
The FDA’s approval is based on two studies that looked at the efficacy and safety of the new diagnostic test. The tests suggest that Axumin could be useful for recurrent prostate cancer cases.
Axumin has shown indications of use for positron emission tomography (PET) imaging in male patients who may have prostate cancer recurrence. Doctors must suspect that the patient has the recurrent cancer due to increased prostate specific antigen (PSA) levels, which are typically detected after the patient receives treatments.
“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” Libero Marzella, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said. “Axumin is shown to provide another accurate imaging approach for these patients.”
For men in the U.S., prostate cancer is the second highest cause of cancer deaths. As such, it is important to have accurate staging for the ideal outcomes and management when treating prostate cancer, especially for men who have recurrence after their primary treatment.
Organizations in this story
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903