The FDA announced its approval today of Axumin, a radioactive diagnostic agent indicated for PET imaging in men with “suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.”

“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Axumin is shown to provide another accurate imaging approach for these patients.”

Two separate studies were used to evaluate Axumin. The first compared Axumin scans of men with suspected recurrence of prostate cancer with the histopathology obtained by biopsy. For the second study, Axumin scans were compared with C11 choline scans in patients with median PSA values of 1.44 ng/mL.

The FDA emphasized in its statement that providers must still be cautious when handling Axumin.

“Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers during administration,” the FDA statement read. “Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent prostate cancer. Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended.”

Axumin is marketed by Blue Earth Diagnostics out of the U.K.