#NETSPOT AAA FREE#
The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability.
#NETSPOT AAA TRIAL#
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 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 recently, 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. Advanced Accelerator Applications would bring to Novartis an expanded pipeline of RLT programs with significant sales potential, including 177Lu-PSMA-R2 entering Phase 1/2 for prostate cancer.Integration of Advanced Accelerator Applications would build on Novartis' expertise in diseases associated with NETs and introduce a new technology platform to Novartis providing an innovative approach to treating cancer.Acquisition would add Lutathera, a first-in-class RadioLigand Therapy (RLT) approved in Europe and under review in the US for neuroendocrine tumors (NETs).Novartis to acquire Advanced Accelerator Applications pending outcome of tender offer and works council consultation.
We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. “The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA.
#NETSPOT AAA GENERATOR#
NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. AAA intends to commercialize the product in the US 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. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing today’s approval, NETSPOT will be made available to the US market as soon as possible. NETSPOT 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 US. NETSPOT received approval following a Priority Review from the FDA. AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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