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EMA Panel Backs Approval of Lutathera for GEP-NETs

Jason M. Broderick @jasoncology
Published: Friday, Jul 21, 2017

Stefano Buono

Stefano Buono
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Lutathera (lutetium [177Lu] oxodotreotide) for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

An adverse event (AE) of any grade was experienced by 96% of those in the Lutathera arm versus 86% of those in the octreotide group. Eighty-six percent and 31% of patients, in the Lutathera and octreotide groups, experienced treatment-related AEs, respectively. Treatment related serious AEs were experienced by 9% of patients treated with Lutathera versus 1% in the octreotide arm. Five patients discontinued the study due to Lutathera-related AEs.
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