RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate

64Cu-Dotatate is a PET diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors (NETs). RadioMedix Inc. has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA in 2019. “If approved, 64Cu-Dotatate will be an exciting new diagnostic agent for the detection of neuroendocrine tumors,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “The FDA Fast Track designation of 64Cu-Dotatate highlights the public health need by enhancing the availability of diagnostic radiopharmaceuticals for patients with neuroendocrine tumors. 64Cu-Dotatate is anticipated to be the first neuroendocrine PET diagnostic available to all medical centers with PET capability across the country. This will address the shortage or lack of availability of somatostatin analogue PET agents that many geographies in the U.S. are experiencing.” Link to the full press release.