![]() ![]() Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA’s lead investigational therapeutic candidate, Lutetium Lu 177 Dotatate (Lutathera ®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Īdvanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. ![]() For full prescribing information for NETSPOT ® please refer to. The kit has been designated as an orphan drug by the EMA and the FDA. NETSPOT ® is available in two forms: As a drug kit for reconstitution using a Ga 68 generator, and as a ready-to-use injection delivered from local radiopharmacies in select metropolitan areas. ![]() No serious adverse reactions were identified. The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Warnings and Precautions include Ga 68 dotatate contributing to a patient’s overall long-term cumulative radiation exposure. NETSPOT ®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers. In December 2016, the Centers for Medicare & Medicaid Services (“CMS”) granted NETSPOT ® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017. are now delivering 400 doses of NETSPOT ® per month. AAA and its radiopharmacy partners around the U.S. NETSPOT ® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. ![]() The NET community has been very supportive of the innovation NETSPOT ® brings and it is our goal to make it available in as many markets as possible.” The inclusion of NETSPOT ® in the NCCN Guidelines ® for NETs should facilitate coverage from private payors and increase access for many patients. Stefano Buono, Chief Executive Officer of AAA said, “We are pleased to see NETSPOT ® acknowledged by NCCN ® as a clinically relevant tool for the evaluation of patients with NETs. I believe this technology will lead to significant changes in patient management and will guide decisions for targeted therapies.” The ability to image these patients with this compound is crucial to the success of any molecular imaging program. Lale Kostakoglu, MD, MPH, Chief, Nuclear Medicine and Molecular Imaging, at the Icahn School of Medicine at Mount Sinai, stated, “We, as molecular imagers, are very pleased to see this valuable imaging modality be finally integrated into a national management algorithm for neuroendocrine tumors. Ultimately, I believe the use of NETSPOT ® will lead to improved outcomes for patients.” This advance in imaging capability provides treating physicians with enormous insights, enabling better directed surgeries and enhanced decision making regarding different therapeutic options. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care.Įric Liu, MD, FACS, neuroendocrine tumor surgeon and Co-Director, The Neuroendocrine Institute at Rocky Mountain Cancer Center and HealthOne, stated, “As a physician that sees more than 400 patients with NETs per year, I am very grateful to have NETSPOT ® available and included in the NCCN Guidelines ®. NCCN ® is a not-for-profit alliance of leading cancer centers in the U.S. (NASDAQ:AAAP) (“AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that its product NETSPOT ® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network ® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). SAINT-GENIS-POUILLY, France, Ma(GLOBE NEWSWIRE) - Advanced Accelerator Applications S.A. ![]()
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