Biotechnology firm RadioMedix and global nuclear medicine firm Curium have filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for the firms' PET diagnostic radiopharmaceutical copper-64 (Cu-64) DOTATATE.
Cu-64 DOTATATE is a PET diagnostic agent designed to identify the somatostatin receptors of neuroendocrine tumors. The companies announced an exclusive agreement to develop and commercialize Cu-64 DOTATATE in 2018 and received fast-track designation from the FDA for the agent in January last year.
If approved, the agent will be the first Cu-64-labeled radiopharmaceutical for PET/CT imaging, the companies said.
