177 Lutetium Dotatate (Lutathera) is an investigational new drug and has not been approved for use in the United States
Theragnostics is a patient management strategy involving the integration of diagnostics and therapeutics. In oncology, theragnostics merges the fields of tumor diagnostics with that of therapy to try and improve upon existing techniques.
Advanced Accelerator Applications, a radiopharmaceutical company, is developing a theragnostic approach to neuroendocrine tumors (NETs), involving imaging of NETs expressing a specific somatostatin receptor using NETSPOT® and treatment of such tumors using 177 Lutetium Dotatate (Lutathera®), when prescribed by a physician.
NETSPOT®, a kit for the preparation of gallium Ga 68 dotatate, was recently approved by the U.S. Food and Drug Administration for use in both adults and children. The gallium Ga 68 dotatate is injected into patients to determine the location of NETs. It works by targeting and binding to the somatostatin receptor (via the dotatate peptide) and emitting low-level radiation (via the Ga 68 radioisotope) that is detected by an imaging device which uses a technique called positron emission tomography (PET).
lutetium Lu 177 dotatate (Lutathera®) is a radiolabeled therapeutic product that also binds to the same somatostatin receptor expressed by most NETs. However, this radioisotope (Lu 177) is intended to kill tumor cells by emitting a different kind of low-energy, short range radiation. Lutathera® is currently in development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs) in adults. 177 Lutetium Dotatate (Lutathera®) belongs to a new type of treatments called Peptide Receptor Radionuclide Therapy (PRRT).
The US Food and Drug Administration (FDA) is currently evaluating 177 Lutetium Dotatate (Lutathera®). NETSPOT® and 177 Lutetium Dotatate (Lutathera®) are complementary, since both target NETs expressing the same somatostatin receptor. However, NETSPOT® may be used for imaging purposes regardless of any therapeutic treatment choice.
Rachel Levine, Director of Corporate Communications, AAA Corporate Communication