Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2019 Jul 29;12(3):114.
doi: 10.3390/ph12030114.

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

Affiliations
Review

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

Ute Hennrich et al. Pharmaceuticals (Basel). .

Abstract

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 177Lu 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.

Keywords: Lutathera®, [177Lu]Lu-DOTA-TATE; neuroendocrine tumors (NET); peptide receptor radionuclide therapy (PRRT); somatostatin receptor (SSTR); thera(g)nostics.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Structure of [177Lu]Lu-DOTA-TATE (Lutathera®). Simplified writing of complexation [18].
Figure 2
Figure 2
Simplified overview on the mechanism of action of [177Lu]Lu-DOTA-TATE.

Similar articles

Cited by

References

    1. Coenen H.H., Gee A.D., Adam M., Antoni G., Cutler C.S., Fujibayashi Y., Jeong J.M., Mach R.H., Mindt T.L., Pike V.W., et al. Consensus nomenclature rules for radiopharmaceutical chemistry – Setting the record straight. Nucl. Med. Biol. 2017;55:v. doi: 10.1016/j.nucmedbio.2017.09.004. - DOI - PubMed
    1. Coenen H.H., Gee A.D., Adam M., Antoni G., Cutler C.S., Fujibayashi Y., Jeong J.M., Mach R.H., Mindt T.L., Pike V.W., et al. Open letter to journal editors: International consensus radiochemistry nomenclature guidelines. J. Label. Compd. Radiopharm. 2018;61:402–404. doi: 10.1002/jlcr.3604. - DOI - PubMed
    1. FDA Letter of Approval for LUTATHERA®. [(accessed on 23 April 2019)]; Available online: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208700Orig....
    1. Authorization details for Lutathera® in Europe. [(accessed on 23 April 2019)]; Available online: https://www.ema.europa.eu/en/medicines/human/EPAR/lutathera#authorisatio....
    1. Authorization details for Lutathera® in Canada. [(accessed on 23 April 2019)]; Available online: https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.p....