Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera

Novartis expands targeted radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)

Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer

Advanced Accelerator Applications to Build Targeted RadioLigand Therapy Production Facility in Indianapolis

Advanced Accelerator Applications Announces Health Canada Approval of NETSPOT® Diagnostic Imaging Agent Kit to Detect Neuroendocrine Tumours

Advanced Accelerator Applications Announces Start of Phase III Study Investigating Radioligand Therapy Lutathera® as First-Line Treatment in Patients with Advanced GEP-NETs

Advanced Accelerator Applications Announces State of Israel Ministry of Health Approval for Lutathera®, in the Treatment of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare® for Reduction of Kidney Exposure to Radiation During Peptide Receptor Radionuclide Therapy with Lutetium (177Lu) Oxodotreotide (Lutathera®)

Advanced Accelerator Applications Announces Health Canada Approval for Lutathera™, a Treatment for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Advanced Accelerator Applications Receives US FDA Approval for LUTATHERA® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

AAA 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 Radioisotope Therapy (PRRT), a form of targeted treatment comprising a targeting molecule that carries a radioactive component.