Is Lutetium Lu-177 dotatate legal in the US?
Yes, FDA approved for certain gut and pancreas tumors.
AStrong human evidenceFDA approvedas of 2026-10-26
Approved. Lutetium Lu-177 dotatate (Lutathera, Novartis) was approved in January 2018 for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors in adults, and in 2024 the indication was extended to patients aged 12 and older. 2
Read the full Lutetium Lu-177 dotatate page
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Citations
- Strosberg 2017, NEJM: Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors (NETTER-1) doi.org
- Novartis: Lutathera US prescribing information novartis.com
Reference information only, not medical advice. Drawn from the Lutetium Lu-177 dotatate article, fact-checked against the cited sources. No dosing anywhere on this site.