Radiopharmaceutical gains FDA Fast Track designation

RadioMedix and Curium announced that their diagnostic radiopharmaceutical, 64Cu-Dotatate, has received Fast Track designation from the FDA. 64Cu-Dotatate is a PET diagnostic agent being developed to detect neuroendocrine tumors.

The designation means the FDA believes this radiopharmaceutical treats a serious condition and fills an “unmet medical need.”

“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,” Ebrahim Delpassand, MD, CEO of RadioMedix, said in a prepared statement. “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.”

“Our ability to manufacture 64Cu-Dotatate at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued commitment to help patients with neuroendocrine tumors,” Dan Brague, Curium CEO of North America, said in the same statement. “We look forward to partnering with RadioMedix to commercialize this important diagnostic agent pending FDA approval.”