由 Gus Iversen
, Editor in Chief | September 15, 2020
Clinical stage biotechnology company, RadioMedix, and its commercial partner Curium, have announced FDA approval for Detectnet (copper Cu 64 dotatate injection), a PET agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
With a 12.7-hour half-life, Detectnet can be produced centrally and shipped to sites throughout the U.S., helping to alleviate shortages that have delayed access to other somatostatin analogue PET agents.
“Detectnet brings an exciting advancement in the diagnosis of neuroendocrine tumors for healthcare providers, patients, and their caregivers,” said Dr. Ebrahim Delpassand, CEO of RadioMedix, in a statement. “The Phase III results demonstrate the clinical sensitivity and specificity of Detectnet, which will provide a great aid to clinicians in developing an accurate treatment approach for their NET patients.”
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Curium expects to launch Detectnet immediately with doses available through various nuclear pharmacies or directly from Curium.
“Curium is excited to bring the first commercially available Cu 64 diagnostic agent to the U.S. market. Our unique production capabilities and distribution network allow us to deliver to any nuclear pharmacy, hospital or imaging center its full dosing requirements first thing in the morning, to provide scheduling flexibility to the institution and its patients,” said Curium CEO, North America, Dan Brague. “We look forward to joining with healthcare providers and our nuclear pharmacy partners to bring this highly efficacious agent to the market.”