A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

Trial Profile

A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2018

At a glance

  • Drugs Lenvatinib (Primary) ; Sorafenib
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms REFLECT
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 05 Jun 2018 Results (n=954) presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 24 May 2018 According to an Eisai media release, The Prescription Drug User Fee Act (PDUFA) date has been extended from May 24, 2018 to August 24, 2018..
    • 24 May 2018 According to an Eisai media release, based on this trial, the US FDA accepted has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib, for the potential use in the first-line treatment of patients with hepatocellular carcinoma (HCC), commonly referred to as liver cancer. The Prescription Drug User Fee Act (PDUFA) date is before August 24, 2018.
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