Molecular imaging diagnostics firm Blue Earth Diagnostics said it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending market authorization in the European Union (EU) for its Axumin (fluciclovine F-18) PET agent.
The recommendation is for the use of Axumin in PET imaging to detect prostate cancer recurrence men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment, Blue Earth said. The positive opinion will now be reviewed by the European Commission. If approved, Axumin will be the first PET agent indicated for use in men with suspected recurrent prostate cancer in the EU member states as well as Iceland, Liechtenstein, and Norway, the company said.
Information provided by an Axumin PET scan can help physicians localize disease, aiding treatment decisions, Blue Earth said.
