Patients with well- and moderately-differentiated tumors and distant metastases have a 5-year survival probability of 35%. 1 Patient survival with advanced GEP-NETs depends on stage and histology. The estimated incidence, or rate of new cases of NETs, in the United States is approximately 6.98/100,000 per year, while the estimated prevalence for 2014, based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, was 171,321. Some patients develop symptoms arising from the excessive production of hormones by neuroendocrine tumor cells, while others remain clinically silent for years. NETs are rare tumors originating in the neuroendocrine cells of numerous organs, including the gastrointestinal tract, pancreas and lung. 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. (NASDAQ:AAAP) (AAA or the Company), 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. 26, 2018 (GLOBE NEWSWIRE) - Advanced Accelerator Applications S.A. LUTATHERA ® marks first FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT) First-in-class Therapy Demonstrated 79% Improvement in Progression Free Survival in NETTER-1 Phase 3 Study in Midgut NET Patients
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