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A Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Ibritumomab Tiuxetan Injection (ZEVALIN)

Trial Profile

A Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Ibritumomab Tiuxetan Injection (ZEVALIN)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2019

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At a glance

  • Drugs Ibritumomab tiuxetan (Primary)
  • Indications Follicular lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors CASI Pharmaceuticals
  • Most Recent Events

    • 19 Feb 2019 According to a CASI Pharmaceuticals media release, the Company currently is addressing certain requirements provided by the Center for Drug Evaluation (CDE), a part of the NMPA, upon satisfying those requirements, the Company will start the ZEVALIN clinical development program in China.
    • 19 Feb 2019 According to a CASI Pharmaceuticals media release, the National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to allow for a confirmatory clinical trial to evaluate the efficacy and safety of ZEVALIN.The Company previously acquired greater China rights to ZEVALIN from Spectrum and intends to launch ZEVALIN in China as soon as the confirmatory trial is completed and marketing approval is received from the NMPA.
    • 15 Sep 2017 New trial record
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