← Back to The Docket SEP 14 2026
APPROVED · 15 DAYS AGO
— 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
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