Pivotal phase II randomised, double-blind, parallel group study investigating NEPA (netupitant/palonosetron) in chemotherapy-naive patients undergoing cisplatin-based highly emetogenic chemotherapy

Trial Profile

Pivotal phase II randomised, double-blind, parallel group study investigating NEPA (netupitant/palonosetron) in chemotherapy-naive patients undergoing cisplatin-based highly emetogenic chemotherapy

Completed
Phase of Trial: Phase II

Latest Information Update: 08 May 2015

At a glance

  • Drugs Netupitant/palonosetron (Primary) ; Aprepitant; Dexamethasone; Ondansetron; Palonosetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 08 May 2015 According to a Specialised Therapeutics Australia media release, Akynzeo was approved by the Therapeutics Goods Agency (TGA) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. The approval was based on results from this and other III trials (see profile 700201211 and 70056856).
    • 30 Mar 2015 According to Helsinn media release, European Medicines Agency (EMA) has adopted a positive opinion about netupitant/palonestron [AKYNZEO] approval for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy, recommended by Committee for Medicinal Products for Human Use (CHMP). The opinion was based on data from this and other phase II and III trials.
    • 13 Oct 2014 The US FDA approved AKYNZEO for the prevention of CINV based on data from this study and 2 phase III trials, according to a media release from Helsinn and Eisai.
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