![]() Following this approval, NETSPOT ® will be available in Canada. ![]() ![]() This innovative technology supports a more accurate diagnosis and staging of NETs and a more tailored treatment plan. NETSPOT ® is the first and only kit for the preparation of gallium ( 68Ga) oxodotreotide injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected somatostatin receptor positive neuroendocrine tumors (NETs) for localizing primary tumours and their metastases. (AAA), a Novartis company, today announced that Health Canada has approved NETSPOT ® (kit for the preparation of gallium ( 68Ga) oxodotreotide injection) for the evaluation of neuroendocrine tumours ("NETs"). SAINT-GENIS-POUILLY, France, April 7, 2020 /CNW/ - Advanced Accelerator Applications S.A. Despite vast improvements in diagnostic techniques, neuroendocrine tumours remain one of the most elusive cancers to diagnose 1.The safety and clinical benefit of NETSPOT ® was based on a systematic review of the scientific literature on the use of gallium ( 68Ga) oxodotreotide as a radiodiagnostic agent in the management of patients with neuroendocrine tumours (NETs).NETSPOT ® is the first and only kit for the preparation of gallium ( 68Ga) oxodotreotide injection for diagnostic imaging of neuroendocrine tumors.AAA had sales of EUR 109 million in 2016. In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT®and SomaKit TOC(TM)). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018. Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). "With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform." "Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients," said Bruno Strigini, CEO, Novartis Oncology. The transaction would strengthen Novartis' oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs. ![]() Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. Advanced Accelerator Applications (NASDAQ:AAAP) is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® (177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumors (NETs). Novartis announced that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. ![]()
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