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Phase III safety evaluation of intravenous NEPA, a novel fixed antiemetic combination of fosnetupitant and palonosetron, over multiple cycles.

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122Background: NEPA is an oral fixed combination of the selective NK1 receptor antagonist (RA), netupitant (300 mg), and pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), combining two guideline-recommended antiemetic classes… Click to show full abstract

122Background: NEPA is an oral fixed combination of the selective NK1 receptor antagonist (RA), netupitant (300 mg), and pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), combining two guideline-recommended antiemetic classes in a convenient single capsule. Oral NEPA has shown superior prevention of chemotherapy-induced nausea and vomiting (CINV) over oral PALO, sustained efficacy over multiple cycles, and well-established safety in >1500 patients (pts). To offer additional convenience for health care practitioners and pts, an intravenous (IV) formulation of the NEPA fixed combination (fosnetupitant 235 mg/PALO 0.25 mg) was developed. Methods: This randomized, multinational, double-blind, stratified (by gender/country) phase 3 study in chemotherapy-naive pts with solid tumors was designed to assess the safety of a single 30-minute infusion of IV NEPA prior to initial/up to 4 repeated cycles of highly emetogenic chemotherapy (HEC). Patients received either IV NEPA or oral NEPA, both with ora...

Keywords: combination; multiple cycles; safety; combination fosnetupitant; phase iii; palonosetron

Journal Title: Journal of Clinical Oncology
Year Published: 2017

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