FDA Approves Copper Cu 64 Dotatate Injection for Somatostatin Receptor-Positive NETs

September 9, 2020

The Detectnet injection was approved by the FDA for the localization of somatostatin receptor positive neuroendocrine tumors in adult patients.

The FDA has approved the PET agent Detectnet (copper Cu 64 dotatate injection), according to the developer of the injection, RadioMedix, and its commercial partner Curium.

Copper Cu 64 dotatate injection is now indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

“[Copper Cu 64 dotatate injection] brings an exciting advancement in the diagnosis of neuroendocrine tumors for healthcare providers, patients, and their caregivers,” Ebrahim Delpassand, MD, CEO of RadioMedix, said in a press release. “The phase 3 results demonstrate the clinical sensitivity and specificity of [the copper Cu 64 dotatate injection] which will provide a great aid to clinicians in developing an accurate treatment approach for their NET patients.”

“Perhaps most exciting is that the 12.7-hour half-life allows [the copper Cu 64 dotatate injection] to be produced centrally and shipped to sites throughout the US,” Delpassand continued. “This will help alleviate shortages or delays that have been experienced with other somatostatin analogue PET agents.”

Importantly, adverse events (AEs) observed with the copper Cu 64 dotatate injection occurred at a rate of less than 2% in clinical trials and included nausea, vomiting, and flushing. Further, in published trials of the injection, nausea immediately after injection was observed.

Curium indicated it anticipates launching the copper Cu 64 dotatate injection immediately, with doses being made available throughout various nuclear pharmacies or directly from the company.

Reference:

RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S. [news release]. Houston, Texas and St. Louis, Missouri. Published September 7, 2020. Accessed September 8, 2020.