Novatis’ LUTATHERA® Approval: First FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT)

Advanced Accelerator Applications S.A., a Novartis company and leader in nuclear medicine theragnostics, today announced that it has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for 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.

LUTATHERA®, which received orphan drug designation from the FDA, is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of targeted treatment comprising a targeting molecule that carries a radioactive component.

Novartis, to extend the pipeline extension, acquired Advanced Accelerator Applications for $NVS $4 billion. This approval will reckon the success of the futuristic acquisition of Novartis. Novartis believe AAA’s unique radiopharmaceutical pipeline is  complementary to Novartis’ existing oncology offerings. 

About LUTATHERA® (lutetium Lu 177 dotatate) and How it Works

LUTATHERA® is a lutetium Lu 177-labeled somatostatin analog peptide. This first-in-class drug belongs to a class of treatments called Peptide Receptor Radionuclide Therapy (PRRT). PRRT is a form of targeted treatment comprised of a targeting molecule which carries a radioactive component. Once administered through infusion drip into the bloodstream, the targeting molecule binds to a specific receptor on tumor cells, and is then internalized into the target cells, where the radioactive component destroys the tumor cells from within. LUTATHERA® has received orphan drug designation from the FDA and the European Medicines Agency (EMA). LUTATHERA® has been administered to more than 2,000 patients on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in 10 European countries and in the US under an Expanded Access Program (EAP).