“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” Bruno Strigini, CEO of Novartis Oncology, said in a statement. Novartis noted in its announcement today that the NETTER-1 trial demonstrated a 79% reduction in the risk of disease progression, with an interim median progression-free survival rate of 8.4 months that had yet to max out. Improve the format, traceability, uniformity, and completeness relating to clinical data-including from the Phase III NETTER-1 trial, which generated positive results.
#Netspot advanced accelerator applications update#
Provide a safety update on clinical and nonclinical studies. The first review in December 2016 ended with a Complete Response Letter directing AAA to:Ĭonduct subgroup analyses for gender, age, and racial subgroups, as well as other stratification factors and “important” disease characteristics.
In the U.S., the FDA has set a Prescription Drug User Fee Act (PDUFA) target decision date of January 26, 2018, for Lutathera. Lutathera, which is designed to treat NETs, last month won European Commission approval for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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