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SEP 14 2026
APPROVED · 15 DAYS AGO

Curium — Bexlutry (lutetium Lu 177 dotatate)

for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors

NDA · Standard Review

FDA approved lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

About

Bexlutry is a targeted radiation drug that delivers a radioactive particle directly to certain neuroendocrine tumor cells. It works by binding to a specific protein, called a somatostatin receptor, that is common on the surface of these tumors. This precise delivery of radiation may destroy tumor cells while limiting damage to surrounding healthy tissue.

Pivotal trial

NETTER-3 Phase 3 recruiting NCT06784752

The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden

Source: ClinicalTrials.gov

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