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FDA approves Novartis' Lutathera for GEP-NETs

January 26, 2018 7:08 PM UTC

FDA approved Lutathera (177-Lu-Dotatate) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, including foregut, midgut, and hindgut neuroendocrine tumors. Novartis gained the drug when it acquired Advanced Accelerator Applications S.A. for $3.9 billion in a deal that closed this week (see BioCentury Extra, Oct. 30, 2017).

FDA said Lutathera, which is a radiolabeled somatostatin analog that targets somatostatin receptors, is the first radioactive drug approved in the indication. The European Commission approved Lutathera in September 2017 (see BioCentury Extra, Sept. 29, 2017)...