The FDA has approved the New Drug Application for lutetium Lu 177 dotatate (Bexlutry) injection for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Mechanism of Action Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog that binds to somatostatin receptors, with the highest affinity for subtype 2 somatostatin receptors. Upon binding, it is internalized into somatostatin receptor-expressing cells, including malignant tumors.

Lutetium-177 emits beta-minus radiation that induces cellular damage through the formation of free radicals in receptor-positive and neighboring cells. Clinical Evidence The safety and efficacy of lutetium Lu 177 dotatate were evaluated in 229 patients with progressive, locally advanced/inoperable, or metastatic somatostatin…