Advanced Accelerator Applications and NCI formed a clinical trial agreement: NCI plans to sponsor and conduct a study of Lutathera in patients with inoperable pheochromocytoma and paraganglioma.
Pheochromocytoma is a rare endocrine tumor originating in the adrenal glands. Paraganglioma is a tumor that is closely related to pheochromocytoma and originates from outside the adrenal glands. Both are considered orphan diseases.
Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastro entero pancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera is a peptide receptor radionuclide therapy, which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides. This compound has received orphan drug designation from the European Medicines Agency and the FDA.