U.S. FDA gave green signal to Advanced Accelerator Application’s Lutathera (lutetium Lu 177 dotatate)

U.S. FDA gave green signal to Advanced Accelerator Application’s Lutathera (lutetium Lu 177 dotatate)

U.S. FDA gave green signal to Advanced Accelerator Application’s Lutathera (lutetium Lu 177 dotatate)

U.S. FDA (Food and Drug Administration) approved Advanced Accelerator Application’s Lutathera (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Company: Advanced Accelerator Application

Specific Treatments: gastroenteropancreatic neuroendocrine tumors

Therapeutic Areas: Gastroenterology, Oncology

 

 

General information about Lutathera

Lutathera is supplied as an injection for intravenous administration. The recommended dose is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.

Lutathera (lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog. Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSRT2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized. The beta emission from Lu 177 induces cellular damage by formation of free radicals in somatostatin receptor-positive cells and in neighboring cells.

 

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