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FDA-Approved Novel Agent Appears Promising in GEP-NETs

Pamela L. Kunz, MD
Published Online:6:50 PM, Mon October 21, 2019


Pamela L. Kunz, MD, assistant professor, Division of Oncology, Stanford University School of Medicine, discusses the most recent FDA approval of Lutathera (lutetium [Lu 177] dotatate) for the treatment of patients with gastroenteropancreatic NETs (GEP-NETs), including foregut, midgut, and hindgut tumors.

The agent was approved by the FDA in 2018 for the treatment of patients with somatostatin receptor–positive GEP-NETs. Lutetium 177 is a radiolabeled somatostatin analog, says Kunz. The agent is given to patients by intravenous infusion for 4 doses.

Lutetium 177 represents a new class of therapy across all oncology. Kunz says there is a target on NET cells called the somatostatin receptor, and this receptor is the target for peptides like octreotide. She describes this as a lock and key scenario, where the receptor is the lock while the peptide acts as a key, bringing lutetium 177 along with it.

Kunz concludes that this is a very targeted form of radiation that has demonstrated prolonged progression-free survival as well as overall survival benefit in patients with NETs in the midgut. However, the FDA approval for this agent was expanded to include GEP-NETs after adding retrospective data for GEP-NETs.
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