“We are excited about the approval of NETSPOT ® as it offers physicians additional insight into the patient’s disease burden, enabling them to optimize treatment and care. NETSPOT is a novel patented kit developed by AAA for the preparation of gallium Ga 68 dotatate for injection, for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients using Positron Emission Tomography (PET). Even though NETs have historically been considered as rare tumors (orphan disease), their incidence has grown more than 500 percent over the last 3 decades.In addition, the approval reflects our ongoing commitment to the Canadian neuroendocrine tumour community, including patients, their families and the healthcare professionals dedicated to their care,” said Lyndal Walker, General Manager of Advanced Accelerator Applications in Canada.
and the European Union is approximately 47,300 patients/year. The estimated incidence of NETs for the combined populations of the U.S. in two forms: as a kit for reconstitution using a Ga 68 generator, and as Netspot Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. The product will be available in the U.S. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing approval, Netspot will be made available to the U.S. It is the first approved drug using Ga 68 as a positron emitter. Netspot is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the U.S. Netspot received approval following a Priority Review from the FDA. The FDA has approved Netspot (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Facing Ethical Challenges with Strength and Compassion.
#Netspot neuroendocrine professional#
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