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AUG 7 2026
CRL · 53 DAYS AGO

ITM Isotope Technologies Munich SE — 177Lu-edotreotide

for gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

NDA · Standard Review

About

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are cancers that start in the stomach, intestines, or pancreas and often produce hormones that cause disruptive symptoms. ITM-11 is a targeted radiation therapy where a tumor-seeking molecule delivers a radioactive particle directly to the cancer cells. This focused delivery of radiation could offer a way to treat these slow-growing but difficult tumors.

Pivotal trial

COMPOSE Phase 3 active not recruiting NCT04919226

The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Source: ClinicalTrials.gov

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