Sept. 25 Quick Takes: Novartis’ Lutathera meets primary for first-line GEP-NETs
Plus: Japan’s latest drug approvals and updates from Junshi, Adela, AbbVie, I-Mab, Novo, Valo, BridgeBio, GSK, Scynexis
Novartis AG (SIX:NOVN; NYSE:NVS) said radioligand therapy Lutathera 177Lu-Dotatate showed a significant progression-free survival benefit in the Phase III NETTER-2 trial as first-line therapy for gastroenteropancreatic neuroendocrine tumors, meeting the study’s primary endpoint. Lutathera also showed a benefit on objective response rate in the study, which compared the radioligand treatment plus long-acting octreotide with long-acting, high-dose octreotide alone; Novartis said it is the first radioligand therapy to show a clinical benefit in a first-line setting. The pharma will discuss the data with regulators ahead of a planned submission.
Japan’s Ministry of Health, Labour and Welfare approved a basket of drugs including β-amyloid-targeting antibody Leqembi lecanemab from Biogen Inc. (NASDAQ:BIIB) and Eisai Co. Ltd. (Tokyo:4523) to treat Alzheimer’s disease; respiratory syncytial virus vaccine Arexvy from GSK plc (LSE:GSK; NYSE:GSK) for subjects aged 60 and older; CD3xCD20 bispecific Epkinly epcoritamab from AbbVie Inc. (NYSE:ABBV) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat large B cell lymphoma; and SLC9A3 inhibitor Phozevel tenapanor from Ardelyx Inc. (NASDAQ:ARDX) and Kyowa Kirin Co. Ltd. (Tokyo:4151) to treat hyperphosphatemia in chronic kidney disease patients. The European Commission also approved epcoritamab as Tepkinly to treat diffuse large B cell lymphoma...