Lutathera Orphans: State of the Art and Future Application of Radioligand Therapy with Lu-DOTATATE

Overview

Journal Pharmaceutics

Publisher MDPI

Date 2023 Apr 28

PMID 37111596

Authors

Luca Urso

Alberto Nieri

Licia Uccelli

Angelo Castello

Paolo Artioli

Corrado Cittanti

Maria Cristina Marzola

Luigia Florimonte

Massimo Castellani

Sergio Bissoli

Francesca Porto

Alessandra Boschi

Laura Evangelista

Mirco Bartolomei

Affiliations

Soon will be listed here.

Abstract

Lutathera is the first EMA- and FDA-approved radiopharmaceutical for radioligand therapy (RLT). Currently, on the legacy of the NETTER1 trial, only adult patients with progressive unresectable somatostatin receptor (SSTR) positive gastroenteropancreatic (GEP) neuroendocrine neoplasms (NET) can be treated with Lutathera. Conversely, patients with SSTR-positive disease arising from outside the gastroenteric region do not currently have access to Lutathera treatment despite several papers in the literature reporting the effectiveness and safety of RLT in these settings. Moreover, patients with well-differentiated G3 GEP-NET are also still "Lutathera orphans", and retreatment with RLT in patients with disease relapse is currently not approved. The aim of this critical review is to summarize current literature evidence assessing the role of Lutathera outside the approved indications. Moreover, ongoing clinical trials evaluating new possible applications of Lutathera will be considered and discussed to provide an updated picture of future investigations.

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