Lutathera: The First FDA- and EMA-Approved Radiopharmaceutical for Peptide Receptor Radionuclide Therapy.

As the first radiopharmaceutical for Peptide Receptor Radionuclide Therapy (PRRT), Lutathera was approved by the EMA in 2017 and the FDA in 2018 for the treatment of somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumors. Using the concept of PRRT, Lutathera combines the radionuclide Lu with the somatostatin analogue DOTA-TATE, thus delivering ionizing radiation specifically to tumor cells expressing somatostatin receptors. As a result, DNA single- and double-strand breaks are provoked, in case of double-strand breaks leading to cell death of the tumor and its SSTR-positive lesions.