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Novartis:FDA Approves Lutathera For Gastroenteropancreatic Neuroendocrine Tumors

Novartis AG (NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application or NDA for Lutathera for treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.

Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) — a somatostatin analog peptide designed to target tumors with radiolabeled molecules that bind to specific receptors expressed by the tumor — is the first radiopharmaceutical approved for the treatment of gastroenteropancreatic neuroendocrine tumors.

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 treatment comprising of a targeting molecule that
carries a radioactive component.

The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death within the Lutathera plus best standard of care arm (octreotide LAR 30mg every four weeks) compared to 60 mg of octreotide LAR alone (hazard ratio 0.21, 95% CI; 0.13-0.32; p<00.001).

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