Abstract
LutatheraⓇ injection is the first peptide receptor radionuclide therapy radiopharmaceutical in Japan for the treatment of somatostatin receptor（SSTR） positive neuroendocrine tumor（NET）. After somatostatin analogue labeled with radioactive Lutetium 177（177Lu） is administered, it binds to somatostatin receptors, is taken up into tumor cells, and beta rays released from 177Lu induce DNA damage and exert a cell growth-inhibitory effect. International Phase III study NETTER -1 demonstrated the efficacy and safety of this product in patients with SSTR-positive, unresectable or metastatic midgut NET. LutatheraⓇ was approved in 31 European countries in September 2017, followed by the US, Canada, South Korea, Taiwan, and other countries. In Japan, efficacy and safety were confirmed in a Japanese phase I/II study in patients with SSTR positive unresectable or metastatic pancreatic, gastrointestinal, or pulmonary NET, and approval was obtained in June 2021.
