NANETS 2017 Annual Symposium
Advanced Accelerator Applications Announces New England Journal of Medicine Publication of NETTER-1 Phase III Results
AAA today announced that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating 177Lutetium Dotatate, an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (“NETs”).
Advanced Accelerator Applications Announces New England Journal of Medicine Publication of Lutathera® NETTER-1 Phase III Results
Advanced Accelerator Applications CEO Provides Progress Report on Corporate Developments of 2016; Asserts Confidence in Ability to Address FDA Comments on Lutathera® NDA
Advanced Accelerator Applications to Present at 35th Annual J.P. Morgan Healthcare Conference
AAA today announced that the company is scheduled to present at the 35th Annual J.P. Morgan Healthcare Conference, January 9-12, 2017, in San Francisco, CA.
Stefano Buono, Chief Executive Officer; Gerard Ber, Chief Operating Officer; and Heinz Mäusli, Chief Financial Officer will present on Wednesday, January 11, 2017 at 11:30 a.m. PST.
A live and archived webcast of the Company’s presentation will be available on the Investor Relations page.
Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors
AAA today announced that following the issuance of a previously disclosed Discipline Review Letter (DRL) in November, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
No additional clinical studies were requested in the CRL and there were no comments at this time on other sections of the NDA submission.
Advanced Accelerator Applications Announces European Commission Approval of SomaKit TOC™
AAA today announced that following a positive opinion issued by the European Medicines Agency in October 2016, the European Commission has approved SomaKit TOC™ 40 μg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNETs) for localizing primary tumors and their metastases. The drug has 10-year orphan market exclusivity in the European territory.