The Food and Drug Administration (FDA) has approved DetectnetTM (copper Cu 64 dotatate; RadioMedix and Curium), a radioactive diagnostic agent, for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NET) in adult patients.
Detectnet works by binding to somatostatin receptors with highest affinity for subtype 2 receptors. Based upon the intensity of the signals, PET images obtained using Detectnet indicate the presence and density of somatostatin receptors in tissues.
The approval of Detectnet was based on 2 single-center, open-label studies. Study 1 included a total of 63 patients, of which 42 had known or suspected NET. Study 2 included 112 patients with a known history of NET. Detectnet images were interpreted as either positive or negative for NET by 3 independent readers who were blinded to clinical information and other imaging results.
Findings from both studies demonstrated that Detectnet showed clinical specificity and sensitivity in the detection of NET. As for safety, the reported adverse reactions included nausea, vomiting, and flushing.
“Perhaps most exciting is that the 12.7-hour half-life allows Detectnet to be produced centrally and shipped to sites throughout the US,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “This will help alleviate shortages or delays that have been experienced with other somatostatin analogue PET agents.”
Curium expects to launch Detectnet immediately through various nuclear pharmacies or directly from Curium.
- RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the US. https://www.globenewswire.com/news-release/2020/09/08/2089691/0/en/RadioMedix-and-Curium-Announce-FDA-Approval-of-Detectnet-copper-Cu-64-dotatate-injection-in-the-U-S.html. Accessed September 9, 2020.
- Detectnet [package insert]. Maryland Heights, MO: Curium US LLC; 2020.